GEI · Class II · 21 CFR 878.4400

FDA Product Code GEI: Electrosurgical, Cutting & Coagulation & Accessories

FDA product code GEI covers electrosurgical cutting and coagulation devices and their accessories.

These systems use high-frequency electrical current to cut tissue and control bleeding simultaneously during surgical procedures. They are among the most widely used tools in operating rooms across all surgical specialties.

GEI devices are Class II medical devices, regulated under 21 CFR 878.4400 and reviewed by the FDA General & Plastic Surgery panel. Reusable devices require validated reprocessing instructions.

Leading manufacturers include Arthrocare Corp., Valleylab, Inc. and Conmedcorp.

2316
Total
2316
Cleared
111d
Avg days
1976
Since
2316 devices
1321–1344 of 2316
Cleared Aug 30, 2001
MODIFICATION TO:ENDIUS BIPOLAR SHEATH
K012488
Endius, Inc.
General & Plastic Surgery · 27d
Cleared Aug 22, 2001
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
K012129
Ortho Development Corp.
General & Plastic Surgery · 44d
Cleared Jul 19, 2001
ENTEC EVAC PLASMA WAND
K011279
Arthrocare Corp.
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
ARTHROCARE CONTROLLER, MODEL H2000
K011634
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Jun 15, 2001
NTERO NOMAD SYSTEM
K010815
Ntero Surgical, Inc.
General & Plastic Surgery · 88d
Cleared Jun 11, 2001
EN BLOC BIOPSY SYSTEM
K003190
Neothermia Corp.
General & Plastic Surgery · 243d
Cleared May 31, 2001
ESU HANDSWITCHING PENCIL
K001442
Surgex, Inc.
General & Plastic Surgery · 388d
Cleared May 18, 2001
SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
K010710
Seedling Enterprises., LLC
General & Plastic Surgery · 70d
Cleared May 14, 2001
DENSTAT
K010465
Elmed, Inc.
General & Plastic Surgery · 87d
Cleared May 03, 2001
BIPOLAR PENCIL, MODEL 3901-002, 3900-002
K010487
Medtronic PS Medical
General & Plastic Surgery · 72d
Cleared May 03, 2001
MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
K010661
Tissuelink Medical, Inc.
General & Plastic Surgery · 63d
Cleared Apr 27, 2001
MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
K010662
Tissuelink Medical, Inc.
General & Plastic Surgery · 57d
Cleared Apr 13, 2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
K010956
Boston Scientific Corp
General & Plastic Surgery · 14d
Cleared Apr 11, 2001
BIPOLAR TRIGGER-FLEX PROBE
K003126
Ellman Intl., Inc.
General & Plastic Surgery · 188d
Cleared Apr 10, 2001
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS
K002000
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 284d
Cleared Apr 09, 2001
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150
K002981
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 196d
Cleared Apr 09, 2001
RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR
K003676
Rita Medical Systems
General & Plastic Surgery · 131d
Cleared Apr 09, 2001
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
K010265
Baylis Medical Co., Inc.
General & Plastic Surgery · 73d
Cleared Apr 02, 2001
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
K010010
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Apr 02, 2001
BIPOLAR COAGULATION SYSTEM
K010112
Enable Medical Corp.
General & Plastic Surgery · 80d
Cleared Apr 02, 2001
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION
K010192
Antyllos Medizintechnik GmbH
General & Plastic Surgery · 70d
Cleared Mar 26, 2001
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
K010013
Valleylab, Inc.
General & Plastic Surgery · 83d
Cleared Mar 22, 2001
ENDIUS BIPOLAR SHEATH
K003897
Endius, Inc.
General & Plastic Surgery · 94d
Cleared Mar 01, 2001
INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF
K003717
Tekno Medical Optik-Chirurgie GmbH & Co.
General & Plastic Surgery · 87d