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 4 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203183 | CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) | Bolder Surgical, LLC | 2021-05-06 | Traditional | PDF ↗ |
| K203580 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2021-04-30 | Traditional | PDF ↗ |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Olympus Winter & Ibe GmbH | 2021-04-28 | Traditional | PDF ↗ |
| K193070 | VIVACE Electrosurgical Device | ShenB Co., Ltd. | 2021-04-26 | Traditional | PDF ↗ |
| K210338 | Edge Insulated Blade Electrode | Covidien, LLC | 2021-04-15 | Traditional | PDF ↗ |
| K203795 | Star RF Electrode, VIVA RF Electrode | Starmed Co., Ltd. | 2021-04-01 | Traditional | PDF ↗ |
| K202917 | LigaSure Exact Dissector, Nano-coated | Covidien, LLC | 2021-03-23 | Traditional | PDF ↗ |
| K210526 | Medline Cautery Tip Cleaner | Medline Industries, Inc. | 2021-03-12 | Traditional | PDF ↗ |
| K202988 | Tixel System | Novoxel , Ltd. | 2021-02-25 | Traditional | PDF ↗ |
| K203494 | Nissha Medical Technologies Neutral Electrodes | Nissha Medical Technologies, Ltd. | 2021-02-23 | Traditional | PDF ↗ |
| K203522 | Surn5 Electrosurgical Argon Beam Generator and Accessories | Surnic Corporation | 2021-02-22 | Traditional | PDF ↗ |
| K203299 | CellFX System | Pulse Biosciences, Inc. | 2021-02-02 | Traditional | PDF ↗ |
| K191878 | DEX Device | Dex Surgical | 2021-01-29 | Traditional | PDF ↗ |
| K202199 | BTL-899ST | Btl | 2021-01-26 | Traditional | PDF ↗ |
| K201066 | ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length | Ethicon Endo-Surgery, LLC | 2021-01-22 | Traditional | PDF ↗ |
| K201696 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length | Ethicon Endo-Surgery, LLC | 2021-01-22 | Traditional | PDF ↗ |
| K202415 | VirtueRF | ShenB Co., Ltd. | 2021-01-22 | Traditional | PDF ↗ |
| K201685 | Potenza | Jeisys Medical, Inc. | 2021-01-19 | Traditional | PDF ↗ |
| K202880 | J-Plasma Precise FLEX Handpiece | Apyx Medical Corporation (Formerly Bovie Medical Corporation | 2021-01-04 | Traditional | PDF ↗ |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | Aesculap, Inc. | 2020-12-18 | Special | PDF ↗ |
| K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System | ArthroCare Corporation | 2020-12-18 | Traditional | PDF ↗ |
| K201735 | PlaDuo System | ShenB Co., Ltd. | 2020-12-14 | Traditional | PDF ↗ |
| K200372 | Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil | Modern Medical Equipment Manufacturing, Ltd. | 2020-11-30 | Traditional | PDF ↗ |
| K200931 | RF Surgical Generator | Fulwell, LLC | 2020-11-24 | Traditional | PDF ↗ |
| K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft | New Deantronics Taiwan , Ltd. | 2020-11-20 | Traditional | PDF ↗ |
| K200472 | Viveve System | Viveve Medical, Inc. | 2020-11-18 | Traditional | PDF ↗ |
| K192621 | Medical RF | Triworks Group Srl | 2020-11-06 | Traditional | PDF ↗ |
| K202558 | Ellusa Bipolar Wands | Ellusa, LLC | 2020-11-02 | Traditional | PDF ↗ |
| K202562 | Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set | Ellusa, LLC | 2020-11-02 | Traditional | PDF ↗ |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | Aesculap, Inc. | 2020-10-30 | Special | PDF ↗ |
| K201884 | ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm | Microline Surgical, Inc. | 2020-10-21 | Traditional | PDF ↗ |
| K201129 | Medline Smoke Evacuation Pencil | Medline Industires, Inc. | 2020-10-16 | Traditional | PDF ↗ |
| K202114 | CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 | Bolder Surgical, LLC | 2020-10-06 | Traditional | PDF ↗ |
| K201221 | Electrosurgical Generator | New Deantronics Taiwan , Ltd. | 2020-09-28 | Traditional | PDF ↗ |
| K201224 | Electrosurgical Generator and Accessories | Medrange | 2020-09-18 | Traditional | PDF ↗ |
| K201738 | SubNovii Advanced Plasma Technology | Cartessa Aesthetics | 2020-09-10 | Traditional | PDF ↗ |
| K193201 | BTL-785F | Btl | 2020-08-21 | Traditional | PDF ↗ |
| K201637 | Aurora Evacuator +Coag | Rebound Therapeutics | 2020-08-12 | Traditional | PDF ↗ |
| K193355 | Electrodes Handpieces for Mygen V-1000 RF System | RF Medical Co., Ltd. | 2020-08-03 | Special | PDF ↗ |
| K201833 | BiPad Hand Activated, Disposable Bipolar Electrocautery Cords | Bipad Surgical, Inc. | 2020-07-31 | Traditional | PDF ↗ |
| K193601 | Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 2020-07-24 | Traditional | PDF ↗ |
| K201150 | InMode RF Multi-System | InMode , Ltd. | 2020-07-22 | Traditional | PDF ↗ |
| K201018 | Encision AEM enTouch 2X Scissor | Encision, Inc. | 2020-07-15 | Special | PDF ↗ |
| K200947 | InMode System with the Morhpeus8 Applicators | InMode , Ltd. | 2020-07-02 | Traditional | PDF ↗ |
| K201164 | Venus Viva MD Device | Venus Concept USA, Inc. | 2020-06-26 | Traditional | PDF ↗ |
| K200875 | ArtiSential Laparoscopic Instruments - Electrodes | Livsmed, Inc. | 2020-06-17 | Special | PDF ↗ |
| K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde | Modern Medical Equipment Manufacturing, Ltd. | 2020-06-16 | Traditional | PDF ↗ |
| K201063 | DANNIK Disposable Monopolar Laparoscopic Instrument | Dannik | 2020-06-09 | Special | PDF ↗ |
| K201212 | Voyant Open Fusion Device | Applied Medical Resources Corp. | 2020-06-05 | Special | PDF ↗ |
| K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector | Ethicon Endo-Surgery | 2020-05-27 | Traditional | PDF ↗ |
| K191847 | Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps | Adeor Medical AG | 2020-05-22 | Traditional | PDF ↗ |
| K192265 | gi-4000 Electrosurgical Generator | United States Endoscopy Group, Inc. | 2020-05-21 | Traditional | PDF ↗ |
| K200169 | VFS1 Bipolar Electrosurgical Generator | FHC, Inc. | 2020-05-14 | Traditional | PDF ↗ |
| K200501 | ArtiSential Laparoscopic Instrument-Electrodes | Livsmed, Inc. | 2020-05-11 | Traditional | PDF ↗ |
| K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020-05-11 | Traditional | PDF ↗ |
| K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | Ethicon Endo-Surgery, LLC | 2020-05-11 | Traditional | PDF ↗ |
| K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor | Covidien, LLC | 2020-05-07 | Traditional | PDF ↗ |
| K200185 | SYLFIRM X | VIOL Co., Ltd. | 2020-04-22 | Traditional | PDF ↗ |
| K200559 | CarpX | Pavmed, Inc. | 2020-04-20 | Traditional | PDF ↗ |
| K200300 | VivAer Stylus | Aerin Medical, Inc. | 2020-04-13 | Special | PDF ↗ |
| K200598 | Voyant Maryland Fusion Device | Applied Medical Resources Corp. | 2020-04-08 | Special | PDF ↗ |
| K193591 | ARC 400 | Bowa-Electronics GmbH & Co. KG | 2020-04-02 | Traditional | PDF ↗ |
| K191065 | Venus VivaTM | Venus Concept USA, Inc. | 2020-04-01 | Traditional | PDF ↗ |
| K200455 | Trigger Switch and Cord | New Deantronics Taiwan , Ltd. | 2020-03-31 | Traditional | PDF ↗ |
| K193579 | PlasmaBlade X 3.0S LIGHT | Medtronic Navigation | 2020-03-24 | Traditional | PDF ↗ |
| K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | Megadyne Medical Products, Inc. | 2020-03-24 | Traditional | PDF ↗ |
| K191612 | Encision AEM Monopolar Laparoscopic Instruments and Accessories | Encision Incorporated | 2020-03-20 | Traditional | PDF ↗ |
| K191583 | PhotonBlade with Smoke Evacuation | Invuity, Inc. | 2020-03-06 | Traditional | PDF ↗ |
| K192813 | Plasma IQ | Neauvia North America, Inc. | 2020-03-06 | Traditional | PDF ↗ |
| K193019 | DANNIK Disposable Monopolar Laparoscopic Instrument | Dannik | 2020-03-04 | Traditional | PDF ↗ |
| K193356 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC | 2020-03-02 | Traditional | PDF ↗ |
| K192545 | Potenza | Jeisys Medical Incorporated | 2020-02-20 | Traditional | PDF ↗ |
| K190909 | ArtiSential Bipolar Fenestrated Forceps | Livsmed, Inc. | 2020-02-13 | Traditional | PDF ↗ |
| K193587 | Sutter Swyng non-stick bipolar forceps, single-use | Sutter Medizintechnik GmbH | 2020-02-10 | Traditional | PDF ↗ |
| K183148 | OKLand Patient Return Electrode Pad | Auckland Medical Polymer(Tianjin) Co., Ltd. | 2020-02-04 | Traditional | PDF ↗ |
| K193611 | Viveve 2.0 System | Viveve Medical, Inc. | 2020-01-16 | Special | PDF ↗ |
| K183284 | INTRAcel RF Microneedle System | Jeisys Medical, Inc. | 2020-01-15 | Traditional | PDF ↗ |
| K192715 | CRF Radiofrequency Ablation System | Cambridge Interventional, LLC | 2020-01-07 | Traditional | PDF ↗ |
| K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD , Ltd. | 2019-12-27 | Special | PDF ↗ |
| K192471 | RHIN1 Stylus | Aerin Medical, Inc. | 2019-12-20 | Traditional | PDF ↗ |
| K191234 | APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets | Erbe Elektromedizin GmbH | 2019-12-20 | Traditional | PDF ↗ |
| K193292 | Voyant 5mm Fusion Device, Voyant Maryland Fusion Device | Applied Medical Resources Corp. | 2019-12-20 | Special | PDF ↗ |
| K193018 | Surgical Direct Hand-held Laparoscopic Instruments | Surgical Direct, Inc. | 2019-12-20 | Traditional | PDF ↗ |
| K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand | ArthroCare Corporation | 2019-12-20 | Traditional | PDF ↗ |
| K193004 | Monopolar Cord | New Deantronics Taiwan , Ltd. | 2019-12-19 | Traditional | PDF ↗ |
| K192224 | BTL-899 | Btl | 2019-12-05 | Traditional | PDF ↗ |
| K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | Us Medical Innovations, LLC | 2019-11-21 | Special | PDF ↗ |
| K192867 | Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019-10-31 | Traditional | PDF ↗ |
| K182605 | HS AMICA devices family | H.S Hospital Service S.P.A | 2019-10-28 | Traditional | PDF ↗ |
| K192518 | Reusable Monopolar Active Cord | Us Endoscopy | 2019-10-25 | Traditional | PDF ↗ |
| K192728 | Agnes | Agnes Medical Co., Ltd. | 2019-10-24 | Special | PDF ↗ |
| K191542 | Apyx Plasma/RF Handpiece | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019-10-11 | Traditional | PDF ↗ |
| K192235 | AEON Laparoscopic Instruments | Lexington Medical, Inc. | 2019-10-11 | Traditional | PDF ↗ |
| K182773 | Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps | Faulhaber Pinzetten Ohg | 2019-10-08 | Traditional | PDF ↗ |
| K192128 | Sutter Arrowtip Monopolar Electrodes | Sutter Medizintechnik GmbH | 2019-10-04 | Traditional | PDF ↗ |
| K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord | Maquet Cardiovascular, LLC | 2019-09-17 | Traditional | PDF ↗ |
| K191599 | NICO Myriad NOVUS | Nico Corporation | 2019-09-13 | Traditional | PDF ↗ |
| K191528 | Venus Legacy Pro Device | Venus Concept USA, Inc. | 2019-09-06 | Traditional | PDF ↗ |
| K182355 | Secret RF Smartcure Applicator with electrodes | Ilooda Co,., Ltd. | 2019-09-06 | Traditional | PDF ↗ |
| K191732 | Sutter RaVoR Bipolar Electrodes | Sutter Medizintechnik GmbH | 2019-08-30 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.