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)
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 10, 2024 | Microline Surgical, Inc. Microscissor Tip (Disposable); Microline Catalog #: 3122. Open, Classified |
GEI | K213127 |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke genera Open, Classified |
GEI | K143145 |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generate Open, Classified |
GEI | K143145 |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke gen Open, Classified |
GEI | K143145 |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated b Open, Classified |
GEI | K143145 |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke gene Open, Classified |
GEI | K143145 |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by el Open, Classified |
GEI | K143145 |
| Nov 13, 2024 | Bard Peripheral Vascular Inc The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the Open, Classified |
GEI | K160754 |
| Nov 1, 2024 | Zimmer, Inc. Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopi Open, Classified |
GEI | K140603 |
| Oct 30, 2024 | Olympus Corporation of the Americas Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U Open, Classified |
GEI | K231777 |
| Oct 25, 2024 | Maquet Cardiovascular, LLC VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 Open, Classified |
GEI | K052274 K153194 |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
MUNCY PACK, Pack Number DYNJ03097D Open, Classified |
GEI | K974279 |
| Aug 8, 2024 | Olympus Corporation of the Americas The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical Open, Classified |
GEI | K023492 |
| Aug 8, 2024 | Olympus Corporation of the Americas The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical Open, Classified |
GEI | K023492 |
| Aug 8, 2024 | Olympus Corporation of the Americas The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical Open, Classified |
GEI | K023492 |
| Jul 23, 2024 | Olympus Corporation of the Americas ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries
Model/Catalog Number: Open, Classified |
GEI | K203277 |
| Jul 11, 2024 | Maquet Cardiovascular, LLC The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, Open, Classified |
GEI | K101274 |
| Jul 11, 2024 | Maquet Cardiovascular, LLC The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, Open, Classified |
GEI | K153194 |
| Jul 3, 2024 | Megadyne Medical Products, Inc. Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode
Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode
Model/Catalog Number: 0835
Software Version: N/A
Produ Open, Classified |
GEI | K031285 |
| Jul 3, 2024 | Megadyne Medical Products, Inc. Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode
Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode
Model/Catalog Number: 0830
Software Version: N/A
Product Descrip Open, Classified |
GEI | K021077 |
| Jul 3, 2024 | Megadyne Medical Products, Inc. Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode
Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode
Model/Catalog Number: 0800
Software Version: N/A
Product Description: Reusable Pat Open, Classified |
GEI | K080741 |
| Jun 24, 2024 | Maquet Cardiovascular, LLC The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, Open, Classified |
GEI | K153194 |
| Jun 24, 2024 | Maquet Cardiovascular, LLC The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following:
1. VasoView Hemopro 2, Model Number: VH-4000.
2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001.
The Open, Classified |
GEI | K101274 |
| Jun 6, 2024 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use. Open, Classified |
GEI | K080741 |
| Apr 30, 2024 | Olympus Corporation of the Americas POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gy Open, Classified |
GEI | K212643 |
| Apr 30, 2024 | Olympus Corporation of the Americas POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gy Open, Classified |
GEI | K212643 |
| Apr 30, 2024 | Olympus Corporation of the Americas POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gy Open, Classified |
GEI | K212643 |
| Feb 20, 2024 | Olympus Corporation of the Americas ESG PK CUTTING FORCEPS, 5MM, 33CM Open, Classified |
GEI | K203277 |
| Jan 12, 2024 | Maquet Cardiovascular, LLC Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. Open, Classified |
GEI | K153194 |
| Jan 12, 2024 | Maquet Cardiovascular, LLC Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . Open, Classified |
GEI | K052274 |
| Jan 3, 2024 | Covidien Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD Open, Classified |
GEI | K191601 |
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus Open, Classified |
GEI | K233644 |
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus Open, Classified |
GEI | K233644 |
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord Open, Classified |
GEI | K233644 |
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode Open, Classified |
GEI | K133726 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015 Open, Classified |
GEI | K110924 K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015 Open, Classified |
GEI | K110924 K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010 Open, Classified |
GEI | K121426 |
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