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

DateFirm and productCodeLinked 510(k)
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM), REF F-1305
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1303
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1301
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190MM), REF F-1111
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM) , REF F-1110
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM), REF F-1045
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1030
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP INSULATED, OVERALL LENGTH 7-3/4" (195MM), REF F-1003
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF F-1002
Open, Classified
GEIK213386
Dec 3, 2022Carefusion 2200 Inc
CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL LENGTH 7-1/2" (190MM) , REF F-1000
Open, Classified
GEIK213386
Nov 16, 2022Steris Corporation
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applicatio
Terminated
GEIK192265
Sep 26, 2022Olympus Corporation of the Americas
Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Open, Classified
GEIK212643
Sep 26, 2022Olympus Corporation of the Americas
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Open, Classified
GEIK212643
Sep 26, 2022Olympus Corporation of the Americas
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Open, Classified
GEIK212643
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
Open, Classified
GEIK974279
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265
Open, Classified
GEIK911160
Apr 26, 2022Beaver Visitec International, Inc.
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
Open, Classified
GEIK911160
Mar 3, 2022Intuitive Surgical, Inc.
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Completed
GEIK191280
Jan 25, 2022Bolder Surgical, LLC
CoolSeal Generator, REF: CSL-200-50
Terminated
GEIK202114
Jan 13, 2022Covidien Llc
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Terminated
GEIK162941
Jun 9, 2021Olympus Corporation of the Americas
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures whe
Terminated
GEIK081766
Apr 30, 2021CooperSurgical, Inc.
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures
Terminated
GEIK020711
Apr 30, 2021Nico Corp.
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon il
Terminated
GEIK191599
Apr 30, 2021Nico Corp.
NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids un
Terminated
GEIK191599
Mar 5, 2021Covidien
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
Open, Classified
GEIK961771
Feb 1, 2021Bovie Medical Corporation
ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Open, Classified
GEIK152777
K161558
Feb 1, 2021Bovie Medical Corporation
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Open, Classified
GEIK161558
Feb 1, 2021Bovie Medical Corporation
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Open, Classified
GEIK152777
K161558
Jan 4, 2021Aomori Olympus Co., Ltd.
CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Terminated
GEIK902735
Jan 4, 2021Aomori Olympus Co., Ltd.
CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Terminated
GEIK902735
Jan 4, 2021Aomori Olympus Co., Ltd.
SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Terminated
GEIK902735
Jan 4, 2021Aomori Olympus Co., Ltd.
SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Terminated
GEIK902735
Jan 4, 2021Aomori Olympus Co., Ltd.
SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Terminated
GEIK902735
Nov 18, 2020Boston Scientific Corporation
IceFORCE" 2.1 CX L 90 Cryoablation Needle
Completed
GEIK162599
Jun 23, 2020Sutter Medizintechnik GmbH
Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and d
Terminated
GEIK193587
Apr 20, 2020Bovie Medical Corporation
Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for el
Terminated
GEIK151325
K183160
Apr 20, 2020Bovie Medical Corporation
Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cuttin
Terminated
GEIK170188
K183610
Mar 26, 2020Stryker Instruments Div. of Stryker Corporation
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications
Terminated
GEIK182354
Feb 25, 2020Covidien Llc
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BR
Terminated
GEINone listed
Feb 25, 2020Covidien Llc
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
Terminated
GEIK150735
Jan 28, 2020Stryker Instruments Div. of Stryker Corporation
Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Terminated
GEIK182354
Jan 28, 2020Stryker Instruments Div. of Stryker Corporation
Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Terminated
GEIK182354
Jan 28, 2020Stryker Instruments Div. of Stryker Corporation
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Terminated
GEIK182354
Dec 30, 2019Solta Medical Inc
Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgic
Terminated
GEIK132431

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