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

Decided510(k)Device and applicantCode
Oct 7, 2013K133017ESTECH COBRA(R) GENESIS BIPOLAR CLAMP
Estech, Inc.
GEI
Oct 3, 2013K132199DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST
Deroyal Industries, Inc.
GEI
Oct 3, 2013K131435ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,
Ethicon Endo-Surgery, LLC
GEI
Sep 26, 2013K130983GENII ARC SMART ARGON PROBE
Genii, Inc.
GEI
Sep 25, 2013K132665PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC
Ellman International, Inc.
GEI
Sep 16, 2013K130760ELECTROSURGICAL GENERATOR
Beijing Jinhengwei Technology Development Co., Ltd., CN
GEI
Sep 6, 2013K132431THERMAGE CPT SYSTEM
Solta Medical, Inc.
GEI
Sep 6, 2013K132136SINGLE USE GROUNDING PAD
Lccs Products Limited, CN
GEI
Aug 30, 2013K132374BAYLIS MEDICAL RF PERFORATION PROBE V2.0
Baylis Medical Company, Inc., CA
GEI
Aug 26, 2013K131949AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES
Encision, Inc.
GEI
Aug 23, 2013K131012SUTTER BIPOLAR FORCEPS - SUPERGLISS
Sutter Medizintechnik GmbH, DE
GEI
Aug 22, 2013K132099ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND
ArthroCare Corporation
GEI
Aug 22, 2013K130027DISPOSABLE NEUTRAL ELECTRODE GP202
Cathay Manufacturing Corp., CN
GEI
Aug 16, 2013K130793NEWA SKIN THERAPY SYSTEM
Endymion Medical, Ltd., IL
GEI
Aug 13, 2013K123061ACE MONOPOLAR ATTACHMENT
Bioeconeer, Inc., TW
GEI
Aug 9, 2013K131205ARTHROCARE HEAD AND NECK COBLATION WAND
ArthroCare Corporation
GEI
Jul 19, 2013K120510TRANSCEND
Syneron Medical, Ltd., IL
GEI
Jul 12, 2013K123366SURGITRON 4.0 DUAL RF S5-IEC
Ellman International, Inc.
GEI
Jul 2, 2013K122652ARTHROCARE TURBINATOR WAND
ArthroCare Corporation
GEI
Jun 25, 2013K121481INFINI RADIOFREQUENCY SYSTEM
Lutronic Corporation
GEI
May 22, 2013K123662THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
Justright Surgical, LLC
GEI
May 10, 2013K123478STINGRAY BIPOLAR FORCEPS
Stingray Surgical Products
GEI
Apr 18, 2013K122200A3F FRATIONAL
Pollogen, Ltd., IL
GEI
Apr 17, 2013K122716PLASMATRODE SALINE SAFE TUR ELECTRODE
Cook Ireland, Ltd., IE
GEI
Apr 8, 2013K122966XP200
Btl Industries, Ltd.
GEI
Apr 5, 2013K130744LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
Covidien
GEI
Apr 5, 2013K123429OLYMPUS ENERGY POWER SYSTEM (EPS)
Gyrus Acmi, Inc.
GEI
Apr 5, 2013K123353CIQ CONTROLLER, CIQ WANDS
ArthroCare Corporation
GEI
Mar 27, 2013K124029MICROLINE FLEXIBLE LIGATING SHEARS
Microline Surgical, Inc.
GEI
Mar 22, 2013K130596CAIMAN SEAL AND CUT TECHNOLOGY
Aesculap, Inc.
GEI
Jan 30, 2013K123444LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER
Covidien, Formerly Valleylab, A Division of Tyco H
GEI
Jan 25, 2013K122797ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW
Ethicon Endo-Surgery, LLC
GEI
Jan 23, 2013K123310FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
Utah Medical Products, Inc.
GEI
Jan 10, 2013K123201AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
Medtronic Advanced Energy, LLC
GEI
Jan 10, 2013K122383EM3 AEM MONITOR AEM CONNECTORS
Encision, Inc.
GEI
Dec 21, 2012K123260DETACHATIP III
Conmed Corporation
GEI
Dec 21, 2012K123172KOGENT BIPOLAR FORCEPS
Katalyst Surgical, LLC
GEI
Dec 11, 2012K120791AMBIENT TURBOFLASH 90 IFS
Arthocare Corporation
GEI
Dec 7, 2012K120454SAFEAIR SMOKE PENCIL,
Lna Medical Aps
GEI
Nov 20, 2012K121977PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
Plasma Surgical Limited, GB
GEI
Nov 20, 2012K121085HET BIPOLAR LIGATOR SYSTEM
Het Systems, LLC
GEI
Nov 15, 2012K113380PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
Medtronic, Inc.
GEI
Nov 9, 2012K122580AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES
Encision, Inc.
GEI
Nov 7, 2012K122278BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
Baylis Medical Company, Inc., CA
GEI
Nov 5, 2012K122425VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT
Depuy Mitek, A Johnson & Johnson Company
GEI
Nov 2, 2012K120909EC 2.7 ENDOSCOPIC CUTTER
Medtronic Advanced Energy, LLC
GEI
Oct 25, 2012K123141ENSEAL TRIO TISSUE SEALING DEVICE
Ethicon Endo-Surgery, LLC
GEI
Oct 23, 2012K122092MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM
Medrange Corporation
GEI
Oct 1, 2012K120116SERF ABLATION SYSTEM SERF ABLATION NEEDLE
Thermedical
GEI
Sep 21, 2012K121150ALMA LASERS FAMILY OF PIXEL RF TIPS
Alma Lasers, Inc.
GEI

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