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)
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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2022 | Carefusion 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 |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 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 |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 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 |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1301 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 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 |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190MM), REF F-1111 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM) , REF F-1110 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM), REF F-1045 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 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 |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 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 |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 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 |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF F-1002 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL LENGTH 7-1/2" (190MM) , REF F-1000 Open, Classified |
GEI | K213386 |
| Nov 16, 2022 | Steris 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 |
GEI | K192265 |
| Sep 26, 2022 | Olympus 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 |
GEI | K212643 |
| Sep 26, 2022 | Olympus 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 |
GEI | K212643 |
| Sep 26, 2022 | Olympus 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 |
GEI | K212643 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office 3M COMPANY 3M PAD, GROUNDING SAFETY RING
Model Number: 9165 Open, Classified |
GEI | K974279 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered
Model Number: 221265 Open, Classified |
GEI | K911160 |
| Apr 26, 2022 | Beaver 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 |
GEI | K911160 |
| Mar 3, 2022 | Intuitive Surgical, Inc. DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440 Completed |
GEI | K191280 |
| Jan 25, 2022 | Bolder Surgical, LLC CoolSeal Generator, REF: CSL-200-50 Terminated |
GEI | K202114 |
| Jan 13, 2022 | Covidien Llc LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 Terminated |
GEI | K162941 |
| Jun 9, 2021 | Olympus 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 |
GEI | K081766 |
| Apr 30, 2021 | CooperSurgical, 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 |
GEI | K020711 |
| Apr 30, 2021 | Nico 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 |
GEI | K191599 |
| Apr 30, 2021 | Nico 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 |
GEI | K191599 |
| Mar 5, 2021 | Covidien Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22
Product Number/CFN: 178083, 178093, 178094 Open, Classified |
GEI | K961771 |
| Feb 1, 2021 | Bovie 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 |
GEI | K152777 K161558 |
| Feb 1, 2021 | Bovie 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 |
GEI | K161558 |
| Feb 1, 2021 | Bovie 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 |
GEI | K152777 K161558 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
GEI | K902735 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
GEI | K902735 |
| Jan 4, 2021 | Aomori 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 |
GEI | K902735 |
| Jan 4, 2021 | Aomori 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 |
GEI | K902735 |
| Jan 4, 2021 | Aomori 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 |
GEI | K902735 |
| Nov 18, 2020 | Boston Scientific Corporation IceFORCE" 2.1 CX L 90 Cryoablation Needle Completed |
GEI | K162599 |
| Jun 23, 2020 | Sutter 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 |
GEI | K193587 |
| Apr 20, 2020 | Bovie 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 |
GEI | K151325 K183160 |
| Apr 20, 2020 | Bovie 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 |
GEI | K170188 K183610 |
| Mar 26, 2020 | Stryker 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 |
GEI | K182354 |
| Feb 25, 2020 | Covidien 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 |
GEI | None listed |
| Feb 25, 2020 | Covidien Llc Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084
20884524000081; 10884524001937
20884524001934 Terminated |
GEI | K150735 |
| Jan 28, 2020 | Stryker 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 |
GEI | K182354 |
| Jan 28, 2020 | Stryker 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 |
GEI | K182354 |
| Jan 28, 2020 | Stryker 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 |
GEI | K182354 |
| Dec 30, 2019 | Solta 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 |
GEI | K132431 |
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