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 3 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter | Conmed Corporation | 2023-04-27 | Traditional | PDF ↗ |
| K230539 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023-04-27 | Traditional | PDF ↗ |
| K223932 | SafeAir combi (SFR-combi-US) | Lina Medical Aps | 2023-04-26 | Traditional | PDF ↗ |
| K230499 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023-04-26 | Traditional | PDF ↗ |
| K223784 | Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 | Deltronix Equipamentos Ltda | 2023-04-18 | Traditional | PDF ↗ |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) | Ethicon Endo-Surgery, LLC | 2023-04-13 | Traditional | PDF ↗ |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 | Stryker Sustainability Solutions | 2023-03-28 | Special | PDF ↗ |
| K223488 | ClosureFast Endovenous Radiofrequency Ablation Catheter | Medtronic, Inc. | 2023-03-23 | Traditional | PDF ↗ |
| K230194 | HF Surgery Generator 400KHZ | Richard Wolf Medical Instruments Corporation | 2023-03-22 | Traditional | PDF ↗ |
| K222709 | Retraction, CWM-910T, APOLEX Tite | Chungwoo Co., Ltd. | 2023-03-21 | Traditional | PDF ↗ |
| K220725 | HPR45i | F Care Systems USA, LLC | 2023-03-20 | Traditional | PDF ↗ |
| K223262 | Renuvion® APR Handpiece | Apyx Medical Corporation | 2023-02-23 | Traditional | PDF ↗ |
| K220505 | ATTIVA | Italian Engineering S.R.L. | 2023-02-09 | Traditional | PDF ↗ |
| K220996 | Duoblade | Cnc Technologies | 2023-02-03 | Traditional | PDF ↗ |
| K223158 | LigaSure XP Maryland Jaw Sealer/Divider | Covidien, LLC | 2023-01-23 | Traditional | PDF ↗ |
| K221522 | HF-cables (resusable) | Olympus Winter & Ibe GmbH | 2023-01-19 | Traditional | PDF ↗ |
| K223222 | Plasma IQ | Neauvia North America, Inc. | 2023-01-17 | Special | PDF ↗ |
| K221873 | NeoGen PSR System | Energist Limited | 2023-01-12 | Special | PDF ↗ |
| K223039 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2022-11-28 | Traditional | PDF ↗ |
| K221815 | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) | Baisheng Medical Co., Ltd. | 2022-11-23 | Traditional | PDF ↗ |
| K223292 | TempSure System | Cynosure, LLC | 2022-11-23 | Special | PDF ↗ |
| K213042 | Supra Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2022-11-17 | Abbreviated | PDF ↗ |
| K223110 | truSculpt iD | Cutera, Inc. | 2022-11-03 | Special | PDF ↗ |
| K222032 | NEUROMARK System | Neurent Medical | 2022-10-26 | Traditional | PDF ↗ |
| K222793 | WavelinQ Generator | C.R. Bard, Inc. | 2022-10-17 | Special | PDF ↗ |
| K221574 | LUDWIG Electrosurgical Device | Aesthetics Biomedical | 2022-10-16 | Traditional | PDF ↗ |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | Applied Medical Resources Corporation | 2022-10-14 | Special | PDF ↗ |
| K221989 | The Oligio | Wontech Co., Ltd. | 2022-10-13 | Traditional | PDF ↗ |
| K221830 | Apyx One Console | Apyx Medical Corporation | 2022-10-11 | Traditional | PDF ↗ |
| K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps | Katalyst Surgical, LLC | 2022-10-07 | Traditional | PDF ↗ |
| K220138 | Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP | Led Spa | 2022-10-05 | Traditional | PDF ↗ |
| K212561 | MTX-C1 | Ilooda Co,., Ltd. | 2022-09-27 | Traditional | PDF ↗ |
| K213674 | CellFX System | Pulse Biosciences, Inc. | 2022-09-22 | Traditional | PDF ↗ |
| K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | Stryker Corporation | 2022-09-16 | Traditional | PDF ↗ |
| K222429 | Ellusa Reusable Bipolar Cable | Ellusa, LLC | 2022-09-09 | Special | PDF ↗ |
| K222425 | Ellusa Reusable Neutral Plates | Ellusa, LLC | 2022-09-08 | Special | PDF ↗ |
| K222075 | CellFX System | Pulse Biosciences, Inc. | 2022-09-02 | Traditional | PDF ↗ |
| K221277 | Mygen M-3004 RF Generator M-3004 | RF Medical Co., Ltd. | 2022-09-02 | Traditional | PDF ↗ |
| K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2022-09-02 | Special | PDF ↗ |
| K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System | ArthroCare Corporation | 2022-09-01 | Traditional | PDF ↗ |
| K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer | Conmed Corporation | 2022-08-26 | Traditional | PDF ↗ |
| K221671 | CellFX® System | Pulse Biosciences, Inc. | 2022-08-01 | Traditional | PDF ↗ |
| K221907 | RhinAer® Stylus (FG1393) | Aerin Medical, Inc. | 2022-07-29 | Special | PDF ↗ |
| K221945 | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm | Conmed Corporation | 2022-07-28 | Special | PDF ↗ |
| K220970 | Renuvion APR Handpiece | Apyx Medical Corporation(Formerly Bovie Medical Corporation) | 2022-07-15 | Traditional | PDF ↗ |
| K203013 | AGNES | Agnes Medical Co., Ltd. | 2022-07-14 | Traditional | PDF ↗ |
| K221407 | truSculpt iD | Cutera, Inc. | 2022-07-13 | Traditional | PDF ↗ |
| K212472 | AgeJet | Triworks Group Srl | 2022-07-07 | Traditional | PDF ↗ |
| K213786 | CiRX Single use electrosurgical pencil with non-coated and coated electrode | Ningbo Shun YE Medical Company, Ltd. | 2022-06-27 | Traditional | PDF ↗ |
| K211173 | maxmorespine Bipolar Electrodes | Hoogland Spine Products, GmbH | 2022-06-23 | Traditional | PDF ↗ |
| K213612 | SYLFIRM X | VIOL Co., Ltd. | 2022-06-23 | Traditional | PDF ↗ |
| K211000 | ACUTRON | Ilooda Co,., Ltd. | 2022-06-09 | Traditional | PDF ↗ |
| K210084 | SILKRO | Hironic Co., Ltd. | 2022-06-03 | Traditional | PDF ↗ |
| K211652 | Renuvion Dermal Handpiece, Renuvion Dermal System | Apyx Medical Corporation (Formerly Bovie Medical Corporation | 2022-05-25 | Traditional | PDF ↗ |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) | Stryker Sustainability Solutions | 2022-05-25 | Traditional | PDF ↗ |
| K202106 | Plasmage System | Brera Medical, Inc. | 2022-04-06 | Traditional | PDF ↗ |
| K210693 | PLEXR PLUS | Gmv S.R.L. | 2022-03-22 | Traditional | PDF ↗ |
| K212891 | TempSure System | Cynosure, LLC | 2022-03-18 | Traditional | PDF ↗ |
| K210315 | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps | Modern Medical Equipment Manufacturing, Ltd. | 2022-03-17 | Traditional | PDF ↗ |
| K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart | Conmed Corporation | 2022-03-11 | Traditional | PDF ↗ |
| K211639 | BTL-785W | BTL Industries, Inc. | 2022-03-07 | Traditional | PDF ↗ |
| K213127 | ReNew Disposable Scissor Tips | Microline Surgical, Inc. | 2022-03-02 | Traditional | PDF ↗ |
| K203150 | Cool-tip RF Ablation System E Series | Covidien, LLC | 2022-02-25 | Traditional | PDF ↗ |
| K220384 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2022-02-24 | Special | PDF ↗ |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm Tips | Pollogen, Ltd. | 2022-02-17 | Special | PDF ↗ |
| K220071 | Soniquence Reusable Neutral Plate | Soniquence, LLC | 2022-02-03 | Special | PDF ↗ |
| K213814 | Viveve 2.0 System | Viveve, Inc. | 2022-02-02 | Traditional | PDF ↗ |
| K210727 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2022-02-01 | Abbreviated | PDF ↗ |
| K213317 | ShinEvac Smoke Evacuation Pencil | Shining World Health Care Co., Ltd. | 2022-01-28 | Traditional | PDF ↗ |
| K213696 | ETHICON Megadyne Electrosurgical Generator | Megadyne Medical Products, Inc. | 2022-01-21 | Traditional | PDF ↗ |
| K212093 | Medline Universal Grounding Pad | Medline Industries, Inc. | 2022-01-14 | Traditional | PDF ↗ |
| K213344 | BTL-899A | BTL Industries, Inc. | 2022-01-05 | Traditional | PDF ↗ |
| K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle | Gyrus Acmi, Inc. | 2022-01-04 | Special | PDF ↗ |
| K211172 | Single Use Electrosurgical Knife with Fluid Pump System | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-17 | Traditional | PDF ↗ |
| K202818 | Voyant Fine Fusion Device (EB230) | Applied Medical | 2021-12-16 | Traditional | PDF ↗ |
| K211217 | Profound Matrix | Candela Corporation | 2021-12-16 | Traditional | PDF ↗ |
| K212329 | Plasma IQ | Neauvia North America, Inc. | 2021-12-09 | Traditional | PDF ↗ |
| K203745 | AURORA Evacuator +Coag | Rebound Therapeutics | 2021-12-02 | Traditional | PDF ↗ |
| K211562 | Virtue RF | ShenB Co., Ltd. | 2021-11-23 | Traditional | PDF ↗ |
| K212107 | Reverso | Intelis Instruments , Ltd. | 2021-11-10 | Traditional | PDF ↗ |
| K211019 | Disposable Monopolar Laparoscopic Tips and Reusable Handles | Dannik, LLC | 2021-10-28 | Traditional | PDF ↗ |
| K201520 | The Alma Opus System, Colibri Applicator and Tips | Alma Lasers, Inc. | 2021-10-27 | Traditional | PDF ↗ |
| K210488 | Ultrasonic Surgical & Electrosurgical Generator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-25 | Traditional | PDF ↗ |
| K213386 | Titan Manufacturing Bipolar Forceps | Titan Manufacturing, Inc. | 2021-10-25 | Special | PDF ↗ |
| K212666 | Neuromark System | Neurent Medical | 2021-10-22 | Traditional | PDF ↗ |
| K211170 | Single Use Irrigation bipolar cable | Modern Medical Equipment Manufacturing, Ltd. | 2021-10-19 | Traditional | PDF ↗ |
| K200639 | LAP-iX | Sejong Medical Co., Ltd. | 2021-09-29 | Traditional | PDF ↗ |
| K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action | Olympus Surgical Technologies America | 2021-09-27 | Special | PDF ↗ |
| K212678 | Viveve System, Viveve 2.0 System | Viveve Medical, Inc. | 2021-09-14 | Special | PDF ↗ |
| K211579 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) | Bolder Surgical, LLC | 2021-09-07 | Traditional | PDF ↗ |
| K211444 | CellFX System | Pulse Biosciences, Inc. | 2021-08-25 | Traditional | PDF ↗ |
| K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable Handles | Dannik, LLC | 2021-08-16 | Traditional | PDF ↗ |
| K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter | Venclose, Inc. | 2021-08-03 | Traditional | PDF ↗ |
| K211946 | Soniquence Reusable Bipolar Cable | Soniquence, LLC | 2021-07-16 | Special | PDF ↗ |
| K210492 | InMode RF Pro System | Inmode MD , Ltd. | 2021-07-12 | Traditional | PDF ↗ |
| K211107 | BTL-899 FP | BTL Industries, Inc. | 2021-07-09 | Traditional | PDF ↗ |
| K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | ArthroCare Corporation | 2021-06-24 | Traditional | PDF ↗ |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | Olympus Winter & Ibe GmbH | 2021-05-17 | Traditional | PDF ↗ |
| K210942 | MicroFrance Monopolar and Bipolar Electrosurgical Instruments | Integra Microfrance | 2021-05-14 | Traditional | PDF ↗ |
| K203183 | CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) | Bolder Surgical, LLC | 2021-05-06 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.