ClearanceBrief
Panels › General, Plastic Surgery › Product code GEI · Class 2

Electrosurgical, Cutting & Coagulation & Accessories

Regulation 878.4400

47510(k)s in 12 months (2,321 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
Jun 21, 2018K181085LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated
Covidien
GEI
Jun 19, 2018K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform
Covidien
GEI
Jun 11, 2018K173503Pollogen Legend System
Pollogen, Ltd., IL
GEI
Jun 1, 2018K180189InMode System with Fractora3D/3D-90 Applicators
Inmode MD , Ltd., IL
GEI
May 23, 2018K180403ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating
Ethicon Endo-Surgery, LLC
GEI
May 22, 2018K173405DiLumen Endolumenal Interventional Scissors (DiLumen Is)
Lumendi, LLC
GEI
May 18, 2018K180908Irrigation Tubing Bipolar Cord Set
New Deantronics Taiwan , Ltd., TW
GEI
May 7, 2018K180031Endopath Electrosurgery Probe Plus II
Ethicon Endo-Surgery, LLC
GEI
May 1, 2018K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
ArthroCare Corporation
GEI
Apr 26, 2018K180200ESG-300, APU-300, Pressure Reducer, MAPC Probes
Olympus Winter & Ibe GmbH, DE
GEI
Apr 17, 2018K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5
Olympus Medical Systems Corp., JP
GEI
Apr 13, 2018K180699Voyant Open Fusion Device
Applied Medical Resources Corporation
GEI
Apr 9, 2018K180372Aurora Evacuator
Rebound Therapeutics
GEI
Apr 9, 2018K173889Medline Cautery Electrode (PTFE)
Medline Industries, Inc.
GEI
Apr 6, 2018K180584Viveve RF System, Secure
Viveve, Inc.
GEI
Apr 5, 2018K172368Bipolar Micro-Coagulation Forceps
Gunter Bissinger Medizintechnik GmbH, DE
GEI
Mar 14, 2018K172012star RF Electrode, VIVA RF Electrode
Starmed Co., Ltd., KR
GEI
Mar 2, 2018K173281LigaSure Exact Dissector, Nano-coated
Covidien
GEI
Feb 23, 2018K171869Sutter CURIS RF Generator
Sutter Medizintechnik GmbH, DE
GEI
Feb 15, 2018K173877BOWA Neutral Electrodes
Bowa-Electronics GmbH & Co. KG, DE
GEI
Feb 13, 2018K172624Voyant 5mm Fusion Device
Applied Medical Resources Corporation
GEI
Feb 13, 2018K171825Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
Hunan Handlike Minimally Invasive Surgery Co., Ltd., CN
GEI
Jan 26, 2018K171391Stryker 90-S Max SERFAS Energy Probe
Stryker
GEI
Jan 17, 2018K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
Thermigen, L.L.C
GEI
Jan 8, 2018K173759Thermage CPT System and Accessories
Solta Medical
GEI
Dec 5, 2017K172529Vivaer ARC Stylus
Aerin Medical, Inc.
GEI
Nov 21, 2017K173112LAP-iX
Sejong Medical Co., Ltd., KR
GEI
Nov 20, 2017K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, EN
Ethicon Endo-Surgery, LLC
GEI
Nov 16, 2017K172856Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider
Stryker Sustainability Solutions
GEI
Nov 16, 2017K172535Bipolar applicator CELON ProCurve V
Olympus Winter & Ibe GmbH, DE
GEI
Nov 2, 2017K172757Valleylab FX8 Electrosurgical Platform
Covidien, LLC
GEI
Oct 23, 2017K172805gi-4000 Electrosurgical Generator
United States Endoscopy Group, Inc.
GEI
Oct 17, 2017K171752X-SURGE
Genicon, Inc.
GEI
Oct 13, 2017K172023CELFIRM
VIOL Co., Ltd., KR
GEI
Oct 10, 2017K171593InMode RF System
Inmode MD , Ltd., IL
GEI
Oct 4, 2017K172671HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
Conmed Corporation
GEI
Oct 2, 2017K170054iSurg
Jaco, LLC Dba Macan Manufacturing and Bna Burz North America
GEI
Sep 28, 2017K163442Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
Modern Medical Equipment Manufacturing Limited, CN
GEI
Sep 22, 2017K171262TempSure
Cynosure, Inc.
GEI
Sep 22, 2017K170758Thermage FLX System and Accessories
Solta Medical
GEI
Sep 13, 2017K171359Pollogen Legend+ System
Pollogen, Ltd., IL
GEI
Sep 7, 2017K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
Medtronic Advanced Energy
GEI
Aug 22, 2017K172367Stryker Integrated Bipolar Cord and Tubing Sets
Stryker Instruments
GEI
Aug 22, 2017K171523Monopolar Single Use Laparoscopic Instrument
Getsch+Hiller Medizintechnik GmbH, DE
GEI
Aug 8, 2017K171707GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A
Gowoonsesang Cosmetics Co., Ltd., KR
GEI
Aug 7, 2017K171684Epix Electrosurgical Probe with Smoke Evacuation
Applied Medical Resources Corporation
GEI
Aug 2, 2017K171717AUTOCON III 400
KARL STORZ Endoscopy-America, Inc.
GEI
Jun 13, 2017K170325SECRET RF
Ilooda Co,., Ltd., KR
GEI
Jun 8, 2017K171066BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Covidien, LLC
GEI
May 19, 2017K170908PK AIM
Gyrus Acmi, Inc.
GEI

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