Panels › General, Plastic Surgery › Product code GEI · Class 2
Electrosurgical, Cutting & Coagulation & Accessories
Regulation 878.4400
47510(k)s in 12 months (2,319 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) |
|---|---|---|---|
| Aug 26, 2026 | Olympus Corporation of the Americas POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.
GEI / Electrosurgical, cutting & coagulation & accessories Open, Classified |
GEI | K212643 |
| Aug 3, 2026 | Stryker Corporation STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 Open, Classified |
GEI | K963646 |
| Aug 3, 2026 | Stryker Corporation STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 Open, Classified |
GEI | K963646 |
| Jul 15, 2026 | Maquet Cardiovascular, LLC The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI
00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K10127 Open, Classified |
GEI | K101274 |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. Open, Classified |
GEI | K252150 |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC. Open, Classified |
GEI | K252150 |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC. Open, Classified |
GEI | K252150 |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. Open, Classified |
GEI | K252150 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm
Product Name: PKS Cutting Forceps
Model/Catalog Number: 920005PK
Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm Open, Classified |
GEI | K023492 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm
Product Name: PKS Cutting Forceps
Model/Catalog Number: 920000PK
Product Description: The PKS Cutting Forceps are intended to be passed through Open, Classified |
GEI | K023492 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm
Product Name: PKS Cutting Forceps
Model/Catalog Number: 3005PK
Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm ca Open, Classified |
GEI | K023492 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm
Product Name: HALO PKS Cutting Forceps
Model/Catalog Number: HACF0533
Product Description: The HALO PKS Cutting Forceps are intended to be passed Open, Classified |
GEI | K100896 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus PK Cutting Forceps, 5mm 33cm
Product Name: PK Cutting Forceps
Model/Catalog Number: PK-CF0533
Product Description: An assembly of devices intended to generate and apply radio-frequ Open, Classified |
GEI | K203277 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm
Product Name: Everest Bipolar Cutting Forceps
Model/Catalog Number: 3006
Product Description: The OLYMPUS Everest Bipolar Cutting Open, Classified |
GEI | K023492 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm
Product Name: Everest Bipolar Cutting Forceps
Model/Catalog Number: 3005
Product Description: The OLYMPUS Everest Bipolar Cutting Forcep Open, Classified |
GEI | K023492 |
| Nov 26, 2025 | Stryker Corporation NICO BrainPath;
Product Number/Product Name
NN-8024
BrainPath Shephard's Hook - Greenberg;
NN-8025
BrainPath Shephard's Hook - Sugita;
NN-8026
BrainPath Shephard's Hook - Budde;
NN-8042
BrainPath She Open, Classified |
GEI | K191599 |
| Nov 26, 2025 | Stryker Corporation NICO Myriad Illumination Pack
Product No. NN-1000
11g Illumination Sleeve/Fiber;
Product No. NN-1001
13g Illumination Sleeve/Fiber Open, Classified |
GEI | K191599 K232567 |
| Nov 26, 2025 | Stryker Corporation NICO Myriad Handpiece
Product Number/Product Name:
NN-8000
15x10 MHP;
NN-8001
15x 13 MHP;
NN-8002
15x 25 MHP - MINOP;
NN-8003
13x10 MHP;
NN-8004
13x13 MHP;
NN-8005
15x25 MHP GAAB;
NN-8006
11X10 MHP Open, Classified |
GEI | K191599 |
| Oct 14, 2025 | Lutronic Corporation XERF EFFECTOR 60. Electrosurgical unit. Open, Classified |
GEI | K251327 |
| Sep 26, 2025 | Bard Peripheral Vascular Inc Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sop Open, Classified |
GEI | K160754 K211806 +1 |
| Sep 25, 2025 | Maquet Cardiovascular, LLC Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000.
The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting ki Open, Classified |
GEI | K251238 |
| Aug 19, 2025 | Olympus Corporation of the Americas Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C.
The ESG-410 Electrosurgical Generator is an electrosurgical generator which utili Open, Classified |
GEI | K203277 |
| Aug 19, 2025 | Olympus Corporation of the Americas Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U.
The ESG-410 Electrosurgical Generator is an electro Open, Classified |
GEI | K231777 |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033. Open, Classified |
GEI | K914910 |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000. Open, Classified |
GEI | K914910 |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050. Open, Classified |
GEI | K914910 |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030. Open, Classified |
GEI | K914910 |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020. Open, Classified |
GEI | K914910 |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100. Open, Classified |
GEI | K914910 |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030. Open, Classified |
GEI | K914910 |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020. Open, Classified |
GEI | K914910 |
| Apr 18, 2025 | 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 |
| Apr 16, 2025 | Maquet Cardiovascular, LLC Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2). Open, Classified |
GEI | K101274 |
| Apr 9, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R Open, Classified |
GEI | K012669 |
| Apr 9, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R Open, Classified |
GEI | K100543 |
| Apr 9, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R Open, Classified |
GEI | K012669 |
| Apr 9, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated
Cable, Item Number REF EICA58720R Open, Classified |
GEI | K012669 |
| Feb 11, 2025 | Stryker Corporation stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades Open, Classified |
GEI | None listed |
| Feb 11, 2025 | Stryker Corporation stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades Open, Classified |
GEI | K143145 |
| Jan 6, 2025 | Stryker Corporation 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000)
120V NEPTUNE S ROVER (0711-001-000)
230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG)
230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES) Open, Classified |
GEI | K143145 |
| Jan 6, 2025 | Aerin Medical, Inc. Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile. Open, Classified |
GEI | K200300 |
| Jan 3, 2025 | Maquet Cardiovascular, LLC Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001.
Indicated for use in minimally invasive surgery allowing access for vessel harvesting. Open, Classified |
GEI | K101274 |
| Jan 3, 2025 | Maquet Cardiovascular, LLC VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000.
Indicated for use in minimally invasive surgery allowing access for vessel harvesting. Open, Classified |
GEI | K101274 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and othe Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and o Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and ot Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other sof Open, Classified |
GEI | K864402 |
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