ClearanceBrief
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)
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Top companies in GEI

Company510(k)sRecalls
ArthroCare Corporation865
Conmed Corporation2553
Valleylab690
Megadyne Medical Products, Inc.3231
Covidien4114
Carefusion 2200, Inc.245
Stryker935
Conmedcorp430
Gyrus Acmi, Inc.2120
Bovie Medical2115
Decided510(k)Device and applicantCode
May 6, 2021K203640CoolSeal Reveal
Bolder Surgical, LLC
GEI
May 6, 2021K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
Bolder Surgical, LLC
GEI
Apr 30, 2021K203580ArtiSential Laparoscopic Instruments-Electrodes
Livsmed, Inc., KR
GEI
Apr 28, 2021K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
Olympus Winter & Ibe GmbH, DE
GEI
Apr 26, 2021K193070VIVACE Electrosurgical Device
ShenB Co., Ltd., KR
GEI
Apr 15, 2021K210338Edge Insulated Blade Electrode
Covidien, LLC
GEI
Apr 1, 2021K203795Star RF Electrode, VIVA RF Electrode
Starmed Co., Ltd., KR
GEI
Mar 23, 2021K202917LigaSure Exact Dissector, Nano-coated
Covidien, LLC
GEI
Mar 12, 2021K210526Medline Cautery Tip Cleaner
Medline Industries, Inc.
GEI
Feb 25, 2021K202988Tixel System
Novoxel , Ltd., IL
GEI
Feb 23, 2021K203494Nissha Medical Technologies Neutral Electrodes
Nissha Medical Technologies, Ltd., GB
GEI
Feb 22, 2021K203522Surn5 Electrosurgical Argon Beam Generator and Accessories
Surnic Corporation
GEI
Feb 2, 2021K203299CellFX System
Pulse Biosciences, Inc.
GEI
Jan 29, 2021K191878DEX Device
Dex Surgical, FR
GEI
Jan 26, 2021K202199BTL-899ST
Btl
GEI
Jan 22, 2021K202415VirtueRF
ShenB Co., Ltd., KR
GEI
Jan 22, 2021K201696ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length
Ethicon Endo-Surgery, LLC
GEI
Jan 22, 2021K201066ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL
Ethicon Endo-Surgery, LLC
GEI
Jan 19, 2021K201685Potenza
Jeisys Medical, Inc., KR
GEI
Jan 4, 2021K202880J-Plasma Precise FLEX Handpiece
Apyx Medical Corporation (Formerly Bovie Medical Corporation
GEI
Dec 18, 2020K203461Aesculap Caiman 12 Seal and Cut Technology System
Aesculap, Inc.
GEI
Dec 18, 2020K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System
ArthroCare Corporation
GEI
Dec 14, 2020K201735PlaDuo System
ShenB Co., Ltd., KR
GEI
Nov 30, 2020K200372Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil
Modern Medical Equipment Manufacturing, Ltd., CN
GEI
Nov 24, 2020K200931RF Surgical Generator
Fulwell, LLC
GEI
Nov 20, 2020K202962Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Sm
New Deantronics Taiwan , Ltd., TW
GEI
Nov 18, 2020K200472Viveve System
Viveve Medical, Inc.
GEI
Nov 6, 2020K192621Medical RF
Triworks Group Srl, IT
GEI
Nov 2, 2020K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set
Ellusa, LLC
GEI
Nov 2, 2020K202558Ellusa Bipolar Wands
Ellusa, LLC
GEI
Oct 30, 2020K202938Aesculap Caiman 5 Seal and Cut Technology System
Aesculap, Inc.
GEI
Oct 21, 2020K201884ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpi
Microline Surgical, Inc.
GEI
Oct 16, 2020K201129Medline Smoke Evacuation Pencil
Medline Industires, Inc.
GEI
Oct 6, 2020K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37,
Bolder Surgical, LLC
GEI
Sep 28, 2020K201221Electrosurgical Generator
New Deantronics Taiwan , Ltd., TW
GEI
Sep 18, 2020K201224Electrosurgical Generator and Accessories
Medrange
GEI
Sep 10, 2020K201738SubNovii Advanced Plasma Technology
Cartessa Aesthetics
GEI
Aug 21, 2020K193201BTL-785F
Btl
GEI
Aug 12, 2020K201637Aurora Evacuator +Coag
Rebound Therapeutics
GEI
Aug 3, 2020K193355Electrodes Handpieces for Mygen V-1000 RF System
RF Medical Co., Ltd., KR
GEI
Jul 31, 2020K201833BiPad Hand Activated, Disposable Bipolar Electrocautery Cords
Bipad Surgical, Inc.
GEI
Jul 24, 2020K193601Single Use Electrosurgical Knife
Micro-Tech (Nanjing) Co., Ltd., CN
GEI
Jul 22, 2020K201150InMode RF Multi-System
InMode , Ltd., IL
GEI
Jul 15, 2020K201018Encision AEM enTouch 2X Scissor
Encision, Inc.
GEI
Jul 2, 2020K200947InMode System with the Morhpeus8 Applicators
InMode , Ltd., IL
GEI
Jun 26, 2020K201164Venus Viva MD Device
Venus Concept USA, Inc.
GEI
Jun 17, 2020K200875ArtiSential Laparoscopic Instruments - Electrodes
Livsmed, Inc., KR
GEI
Jun 16, 2020K192542Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster,
Modern Medical Equipment Manufacturing, Ltd., CN
GEI
Jun 9, 2020K201063DANNIK Disposable Monopolar Laparoscopic Instrument
Dannik
GEI
Jun 5, 2020K201212Voyant Open Fusion Device
Applied Medical Resources Corp.
GEI

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