Panels › General, Plastic Surgery › Product code GEI · Class 2
Electrosurgical, Cutting & Coagulation & Accessories
Regulation 878.4400
46510(k)s in 12 months (2,320 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
Top companies in GEI
| Company | 510(k)s | Recalls |
|---|---|---|
| ArthroCare Corporation | 86 | 5 |
| Conmed Corporation | 25 | 53 |
| Valleylab | 69 | 0 |
| Megadyne Medical Products, Inc. | 32 | 31 |
| Covidien | 41 | 14 |
| Carefusion 2200, Inc. | 2 | 45 |
| Stryker | 9 | 35 |
| Conmedcorp | 43 | 0 |
| Gyrus Acmi, Inc. | 21 | 20 |
| Bovie Medical | 21 | 15 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 23, 2022 | K213612 | SYLFIRM X VIOL Co., Ltd., KR | GEI |
| Jun 23, 2022 | K211173 | maxmorespine Bipolar Electrodes Hoogland Spine Products, GmbH, DE | GEI |
| Jun 9, 2022 | K211000 | ACUTRON Ilooda Co,., Ltd., KR | GEI |
| Jun 3, 2022 | K210084 | SILKRO Hironic Co., Ltd., KR | GEI |
| May 25, 2022 | K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) Stryker Sustainability Solutions | GEI |
| May 25, 2022 | K211652 | Renuvion Dermal Handpiece, Renuvion Dermal System Apyx Medical Corporation (Formerly Bovie Medical Corporation | GEI |
| Apr 6, 2022 | K202106 | Plasmage System Brera Medical, Inc. | GEI |
| Mar 22, 2022 | K210693 | PLEXR PLUS Gmv S.R.L., IT | GEI |
| Mar 18, 2022 | K212891 | TempSure System Cynosure, LLC | GEI |
| Mar 17, 2022 | K210315 | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacua Modern Medical Equipment Manufacturing, Ltd., CN | GEI |
| Mar 11, 2022 | K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch Conmed Corporation | GEI |
| Mar 7, 2022 | K211639 | BTL-785W BTL Industries, Inc. | GEI |
| Mar 2, 2022 | K213127 | ReNew Disposable Scissor Tips Microline Surgical, Inc. | GEI |
| Feb 25, 2022 | K203150 | Cool-tip RF Ablation System E Series Covidien, LLC | GEI |
| Feb 24, 2022 | K220384 | ArtiSential Laparoscopic Instruments-Electrodes Livsmed, Inc., KR | GEI |
| Feb 17, 2022 | K220124 | YandR System, VoluDerm Handpiece, VoluDerm Tips Pollogen, Ltd., IL | GEI |
| Feb 3, 2022 | K220071 | Soniquence Reusable Neutral Plate Soniquence, LLC | GEI |
| Feb 2, 2022 | K213814 | Viveve 2.0 System Viveve, Inc. | GEI |
| Feb 1, 2022 | K210727 | HotDog Warming Mattress + Return Electrode Augustine Temperature Management, LLC | GEI |
| Jan 28, 2022 | K213317 | ShinEvac Smoke Evacuation Pencil Shining World Health Care Co., Ltd., TW | GEI |
| Jan 21, 2022 | K213696 | ETHICON Megadyne Electrosurgical Generator Megadyne Medical Products, Inc. | GEI |
| Jan 14, 2022 | K212093 | Medline Universal Grounding Pad Medline Industries, Inc. | GEI |
| Jan 5, 2022 | K213344 | BTL-899A BTL Industries, Inc. | GEI |
| Jan 4, 2022 | K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle Gyrus Acmi, Inc. | GEI |
| Dec 17, 2021 | K211172 | Single Use Electrosurgical Knife with Fluid Pump System Micro-Tech (Nanjing) Co., Ltd., CN | GEI |
| Dec 16, 2021 | K211217 | Profound Matrix Candela Corporation | GEI |
| Dec 16, 2021 | K202818 | Voyant Fine Fusion Device (EB230) Applied Medical | GEI |
| Dec 9, 2021 | K212329 | Plasma IQ Neauvia North America, Inc. | GEI |
| Dec 2, 2021 | K203745 | AURORA Evacuator +Coag Rebound Therapeutics | GEI |
| Nov 23, 2021 | K211562 | Virtue RF ShenB Co., Ltd., KR | GEI |
| Nov 10, 2021 | K212107 | Reverso Intelis Instruments , Ltd., IL | GEI |
| Oct 28, 2021 | K211019 | Disposable Monopolar Laparoscopic Tips and Reusable Handles Dannik, LLC | GEI |
| Oct 27, 2021 | K201520 | The Alma Opus System, Colibri Applicator and Tips Alma Lasers, Inc. | GEI |
| Oct 25, 2021 | K213386 | Titan Manufacturing Bipolar Forceps Titan Manufacturing, Inc. | GEI |
| Oct 25, 2021 | K210488 | Ultrasonic Surgical & Electrosurgical Generator Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., CN | GEI |
| Oct 22, 2021 | K212666 | Neuromark System Neurent Medical, IE | GEI |
| Oct 19, 2021 | K211170 | Single Use Irrigation bipolar cable Modern Medical Equipment Manufacturing, Ltd., CN | GEI |
| Sep 29, 2021 | K200639 | LAP-iX Sejong Medical Co., Ltd., CN | GEI |
| Sep 27, 2021 | K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action Olympus Surgical Technologies America | GEI |
| Sep 14, 2021 | K212678 | Viveve System, Viveve 2.0 System Viveve Medical, Inc. | GEI |
| Sep 7, 2021 | K211579 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) Bolder Surgical, LLC | GEI |
| Aug 25, 2021 | K211444 | CellFX System Pulse Biosciences, Inc. | GEI |
| Aug 16, 2021 | K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable Handles Dannik, LLC | GEI |
| Aug 3, 2021 | K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter Venclose, Inc. | GEI |
| Jul 16, 2021 | K211946 | Soniquence Reusable Bipolar Cable Soniquence, LLC | GEI |
| Jul 12, 2021 | K210492 | InMode RF Pro System Inmode MD , Ltd., IL | GEI |
| Jul 9, 2021 | K211107 | BTL-899 FP BTL Industries, Inc. | GEI |
| Jun 24, 2021 | K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand ArthroCare Corporation | GEI |
| May 17, 2021 | K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action Olympus Winter & Ibe GmbH, DE | GEI |
| May 14, 2021 | K210942 | MicroFrance Monopolar and Bipolar Electrosurgical Instruments Integra Microfrance, FR | GEI |
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