ClearanceBrief
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)
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Top companies in GEI

DateFirm and productCodeLinked 510(k)
Aug 26, 2026Olympus 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
GEIK212643
Aug 3, 2026Stryker Corporation
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Open, Classified
GEIK963646
Aug 3, 2026Stryker Corporation
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Open, Classified
GEIK963646
Jul 15, 2026Maquet 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
GEIK101274
Apr 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Open, Classified
GEIK252150
Apr 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Open, Classified
GEIK252150
Apr 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Open, Classified
GEIK252150
Apr 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Open, Classified
GEIK252150
Mar 25, 2026Olympus 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
GEIK023492
Mar 25, 2026Olympus 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
GEIK023492
Mar 25, 2026Olympus 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
GEIK023492
Mar 25, 2026Olympus 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
GEIK100896
Mar 25, 2026Olympus 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
GEIK203277
Mar 25, 2026Olympus 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
GEIK023492
Mar 25, 2026Olympus 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
GEIK023492
Nov 26, 2025Stryker 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
GEIK191599
Nov 26, 2025Stryker Corporation
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
Open, Classified
GEIK191599
K232567
Nov 26, 2025Stryker 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
GEIK191599
Oct 14, 2025Lutronic Corporation
XERF EFFECTOR 60. Electrosurgical unit.
Open, Classified
GEIK251327
Sep 26, 2025Bard 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
GEIK160754
K211806 +1
Sep 25, 2025Maquet 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
GEIK251238
Aug 19, 2025Olympus 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
GEIK203277
Aug 19, 2025Olympus 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
GEIK231777
Jun 2, 2025Silex Medical, LLC
Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.
Open, Classified
GEIK914910
Jun 2, 2025Silex Medical, LLC
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
Open, Classified
GEIK914910
Jun 2, 2025Silex Medical, LLC
Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
Open, Classified
GEIK914910
Jun 2, 2025Silex Medical, LLC
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
Open, Classified
GEIK914910
Jun 2, 2025Silex Medical, LLC
Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.
Open, Classified
GEIK914910
Jun 2, 2025Silex Medical, LLC
Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
Open, Classified
GEIK914910
Jun 2, 2025Silex Medical, LLC
Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.
Open, Classified
GEIK914910
Jun 2, 2025Silex Medical, LLC
Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020.
Open, Classified
GEIK914910
Apr 18, 2025Maquet 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
GEIK101274
Apr 16, 2025Maquet 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
GEIK101274
Apr 9, 2025MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
Open, Classified
GEIK012669
Apr 9, 2025MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Open, Classified
GEIK100543
Apr 9, 2025MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Open, Classified
GEIK012669
Apr 9, 2025MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
Open, Classified
GEIK012669
Feb 11, 2025Stryker Corporation
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Open, Classified
GEINone listed
Feb 11, 2025Stryker Corporation
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Open, Classified
GEIK143145
Jan 6, 2025Stryker 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
GEIK143145
Jan 6, 2025Aerin Medical, Inc.
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Open, Classified
GEIK200300
Jan 3, 2025Maquet 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
GEIK101274
Jan 3, 2025Maquet 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
GEIK101274
Dec 16, 2024Kirwan 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
GEIK864402
Dec 16, 2024Kirwan 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
GEIK864402
Dec 16, 2024Kirwan 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
GEIK864402
Dec 16, 2024Kirwan 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
GEIK864402
Dec 16, 2024Kirwan 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
GEIK864402
Dec 16, 2024Kirwan 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
GEIK864402
Dec 16, 2024Kirwan 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
GEIK864402

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