FDA Product Code
FDA Product Code GEI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 2,319 records · page 2 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231216 | POTENZA | Jeisys Medical, Inc. | 2024-12-10 | Traditional | PDF ↗ |
| K240897 | Cellinew | VIOL Co., Ltd. | 2024-11-26 | Traditional | PDF ↗ |
| K241157 | Secret MAX Multi-platform RF System | Ilooda Co,., Ltd. | 2024-11-21 | Traditional | PDF ↗ |
| K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator | Livsmed, Inc. | 2024-11-15 | Traditional | PDF ↗ |
| K242286 | Superflow Prime Treatment System (ASP-1M) | Guangzhou Aimira Innovation Technology Co, Ltd. | 2024-11-08 | Traditional | PDF ↗ |
| K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024-11-08 | Traditional | PDF ↗ |
| K231287 | POTENZA | Jeisys Medical, Inc. | 2024-11-05 | Traditional | PDF ↗ |
| K243217 | Legend X Desktop System | Pollogen, Ltd. | 2024-11-01 | Traditional | PDF ↗ |
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | 2024-10-21 | Traditional | PDF ↗ |
| K242204 | Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) | Dongguan Quanding Medical Supplies Co., Ltd. | 2024-09-25 | Traditional | PDF ↗ |
| K241535 | Vybe RF II | ShenB Co., Ltd. | 2024-09-25 | Traditional | PDF ↗ |
| K242044 | FiAPC plus probes | Erbe Elektromedizin GmbH | 2024-08-26 | Traditional | PDF ↗ |
| K241635 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2024-08-05 | Traditional | PDF ↗ |
| K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) | Pulse Biosciences, Inc. | 2024-08-05 | Traditional | PDF ↗ |
| K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024-08-05 | Traditional | PDF ↗ |
| K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | Intuitive Surgical | 2024-08-02 | Traditional | PDF ↗ |
| K240780 | InMode RF System | InMode , Ltd. | 2024-07-24 | Traditional | PDF ↗ |
| K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) | Megadyne Medical Products, Inc. | 2024-07-12 | Traditional | PDF ↗ |
| K241085 | Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | Covidien, LLC | 2024-07-12 | Traditional | PDF ↗ |
| K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2024-07-11 | Traditional | PDF ↗ |
| K240572 | Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6) | Covidien, LLC | 2024-07-01 | Traditional | PDF ↗ |
| K240070 | Profound Matrix | Candela Corporation | 2024-07-01 | Traditional | PDF ↗ |
| K233123 | SILKRO | Hironic Co., Ltd. | 2024-06-24 | Traditional | PDF ↗ |
| K240017 | InMode System with the Morpheus8 90 Applicator | InMode , Ltd. | 2024-06-13 | Traditional | PDF ↗ |
| K240657 | ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L- | Livsmed, Inc. | 2024-06-06 | Traditional | PDF ↗ |
| K241055 | Electro Lube NXT | Steris | 2024-05-31 | Traditional | PDF ↗ |
| K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter | Zhejiang Curaway Medical Technology Co., Ltd. | 2024-05-30 | Traditional | PDF ↗ |
| K233120 | CWM-930S, FIXER DV9 | Chungwoo Co., Ltd. | 2024-05-23 | Traditional | PDF ↗ |
| K233099 | Gladiator | Rohrer Aesthetics, LLC | 2024-05-22 | Traditional | PDF ↗ |
| K240964 | FLOW 90? Wand | ArthroCare Corporation | 2024-05-08 | Special | PDF ↗ |
| K240999 | Legend X Applicator VO | Pollogen, Ltd. | 2024-05-08 | Traditional | PDF ↗ |
| K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027) | Relign Corporation, Subsidiary of Zimmer Biomet | 2024-05-08 | Special | PDF ↗ |
| K240248 | Volnewmer | Classys, Inc. | 2024-04-29 | Traditional | PDF ↗ |
| K232805 | Kronos Electrocautery Device | Single Pass, Inc. | 2024-04-25 | Traditional | PDF ↗ |
| K233849 | BTL-499 | BTL Industries, Inc. | 2024-04-23 | Traditional | PDF ↗ |
| K234147 | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) | Microline Surgical, Inc. | 2024-04-23 | Traditional | PDF ↗ |
| K222958 | mJOULE RF System and Accessories | Sciton, Inc | 2024-04-23 | Traditional | PDF ↗ |
| K233604 | BTL-785S | BTL Industries, Inc. | 2024-03-28 | Traditional | PDF ↗ |
| K233002 | BEED 2,5, BEED 3,8 | Excelsior Resources, LLC | 2024-03-20 | Traditional | PDF ↗ |
| K233642 | InMode RF System | InMode , Ltd. | 2024-03-20 | Traditional | PDF ↗ |
| K232301 | Define RF Microneedling System | Aesthetic Management Partners | 2024-03-14 | Traditional | PDF ↗ |
| K233705 | CellFX Percutaneous Electrode System (SYS3000) | Pulse Biosciences, Inc. | 2024-03-08 | Traditional | PDF ↗ |
| K232703 | Disposable Bipolar Forceps | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | 2024-03-06 | Traditional | PDF ↗ |
| K230837 | PlazMagik | Agnes Medical Co., Ltd. | 2024-02-29 | Traditional | PDF ↗ |
| K233830 | OsteoCool 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2024-02-28 | Traditional | PDF ↗ |
| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) | Maquet Cardiovascular, LLC | 2024-02-27 | Traditional | PDF ↗ |
| K240313 | Oligio X | Wontech Co., Ltd. | 2024-02-22 | Special | PDF ↗ |
| K231985 | Disposable Grounding Pad | Shenzhen Mecun Medical Supply Co., Ltd. | 2024-02-16 | Traditional | PDF ↗ |
| K232072 | AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G | H.S Hospital Service S.P.A | 2024-02-09 | Traditional | PDF ↗ |
| K234140 | VIVA combo RF System (VIVA combo RF System) | Starmed Co., Ltd. | 2024-01-30 | Special | PDF ↗ |
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | Sutter Medizintechnik GmbH | 2024-01-25 | Traditional | PDF ↗ |
| K231405 | Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. | 2024-01-18 | Traditional | PDF ↗ |
| K233615 | Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 | Baisheng Medical Co., Ltd. | 2024-01-08 | Traditional | PDF ↗ |
| K232992 | 10THERMA | Tentech, Inc. | 2023-12-20 | Traditional | PDF ↗ |
| K233374 | Secret Pro | Ilooda Co,., Ltd. | 2023-12-14 | Special | PDF ↗ |
| K232947 | SIRA RFA Electrosurgical Device | Innoblative Designs, Inc. | 2023-12-12 | Special | PDF ↗ |
| K232290 | INTELLIO SHIFT System | ArthroCare Corporation | 2023-12-11 | Traditional | PDF ↗ |
| K231615 | Disposable Endoscopic Bipolar | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | 2023-12-05 | Traditional | PDF ↗ |
| K230621 | LaproGlide Disposable Monopolar PTFE Coated Laparoscopic Probes | Surgical Principals, Inc. | 2023-12-01 | Traditional | PDF ↗ |
| K232033 | HYBRIDknife® flex | Erbe Elektromedizin GmbH | 2023-11-29 | Traditional | PDF ↗ |
| K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) | Relign Corporation | 2023-11-28 | Special | PDF ↗ |
| K233351 | Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force | Hg Innovations, Ltd. | 2023-11-20 | Traditional | PDF ↗ |
| K233346 | Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); | Hg Innovations, Ltd. | 2023-11-20 | Traditional | PDF ↗ |
| K231012 | CoolSeal Trinity | Bolder Surgical, LLC | 2023-11-15 | Traditional | PDF ↗ |
| K222997 | VVR Generator system | Starmed Co., Ltd. | 2023-10-25 | Traditional | PDF ↗ |
| K233147 | PiXel8-RF | Rohrer Aesthetics | 2023-10-25 | Special | PDF ↗ |
| K231327 | POWERSEAL Sealer and Divider | Gyrus Acmi, Inc. | 2023-10-25 | Traditional | PDF ↗ |
| K233185 | MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System | C2dx, Inc. | 2023-10-24 | Special | PDF ↗ |
| K232223 | PlaDuo System | ShenB Co., Ltd. | 2023-10-24 | Traditional | PDF ↗ |
| K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland | Conmed Corporation | 2023-10-23 | Traditional | PDF ↗ |
| K231749 | Radio Frequency System | Shenzhenshi Sincoheren S&T Development Co., Ltd. | 2023-10-19 | Traditional | PDF ↗ |
| K232903 | Legend X Platform | Pollogen, Ltd. | 2023-10-17 | Traditional | PDF ↗ |
| K231495 | The Evolve System with the Transform Applicator | InMode , Ltd. | 2023-10-13 | Traditional | PDF ↗ |
| K232809 | Cross Vascular RF Generator and Footswitch (optional accessory) | Cross Vascular, Inc. | 2023-10-12 | Traditional | PDF ↗ |
| K230650 | Monopolar Electrode Surgical Instrument | Vhmed (Nantong) Co. , Ltd. | 2023-10-12 | Traditional | PDF ↗ |
| K232460 | Disposable electrosurgical pencil (MD1000) | Shenzhen Mecun Medical Supply Co., Ltd. | 2023-10-11 | Traditional | PDF ↗ |
| K232407 | Cautery Protective Actuation System (CPAS) | Safer Surgeries Medical Devices, LLC | 2023-10-06 | Traditional | PDF ↗ |
| K232763 | Electrode Handpieces (VCT, RFTV, BMDT series) | RF Medical Co., Ltd. | 2023-10-04 | Special | PDF ↗ |
| K230467 | BTL-899F | BTL Industries, Inc. | 2023-09-21 | Traditional | PDF ↗ |
| K231146 | AliTight | Alic Iotech, LLC | 2023-09-08 | Traditional | PDF ↗ |
| K221743 | Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes | Jiangsu Bonss Medical Technology Co., Ltd. | 2023-09-07 | Traditional | PDF ↗ |
| K223303 | Spinery RF Ablation System | Axon Spine Medical System | 2023-08-30 | Traditional | PDF ↗ |
| K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) | Kirwan Surgical Products, LLC | 2023-08-25 | Traditional | PDF ↗ |
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | Olympus Winter & Ibe GmbH | 2023-08-18 | Traditional | PDF ↗ |
| K230663 | Density | Jeisys Medical, Inc. | 2023-08-14 | Traditional | PDF ↗ |
| K223856 | NuEra Tight RF Family | Bios S.R.L. | 2023-08-11 | Traditional | PDF ↗ |
| K231126 | Eblator Device | E Surgical, LLC | 2023-08-02 | Traditional | PDF ↗ |
| K231790 | The InMode System with the Morpheus8 Applicators | InMode , Ltd. | 2023-07-20 | Special | PDF ↗ |
| K230968 | VYBE RF Electrosurgical System | ShenB Co., Ltd. | 2023-07-06 | Special | PDF ↗ |
| K223135 | AblatePal Radiofrequency Ablation System | Compal Electronics, Inc. | 2023-06-30 | Traditional | PDF ↗ |
| K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) | ArthroCare Corporation | 2023-06-26 | Traditional | PDF ↗ |
| K223033 | Tixel® 2 System | Novoxel , Ltd. | 2023-06-21 | Traditional | PDF ↗ |
| K231212 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2023-06-21 | Traditional | PDF ↗ |
| K230586 | Renuvion® Micro Handpiece | Apyx Medical Corporation | 2023-06-09 | Traditional | PDF ↗ |
| K230498 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023-06-05 | Traditional | PDF ↗ |
| K222556 | BTL-785X | BTL Industries, Inc. | 2023-05-31 | Traditional | PDF ↗ |
| K230593 | Victan | Jiangsu Haize Medical Scientific Development Co., Ltd. | 2023-05-30 | Traditional | PDF ↗ |
| K230432 | Single Use Bipolar Forceps | Hg Innovations, Ltd. | 2023-05-18 | Traditional | PDF ↗ |
| K223805 | Agnes | Agnes Medical Co., Ltd. | 2023-05-04 | Traditional | PDF ↗ |
| K230539 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023-04-27 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.