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
1177–1200 of 2316
Cleared Aug 20, 2003
TISSUELINK FLOATING BALL MODEL 23-201-1
K032132
Tissuelink Medical, Inc.
General & Plastic Surgery · 40d
Cleared Aug 20, 2003
COBRA COOLED SURGICAL PROBE, MODEL M004159670
K032207
Boston Scientific Corp
General & Plastic Surgery · 33d
Cleared Aug 06, 2003
TRI-LOOP MICROWAVE ABLATION PROBE
K032047
Vivant Medical, Inc.
General & Plastic Surgery · 35d
Cleared Aug 01, 2003
MODIFICATION TO THERMACOOL TC SYSTEM
K032088
Thermage, Inc.
General & Plastic Surgery · 25d
Cleared Jul 29, 2003
STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)
K032062
Stellartech Research Corp.
General & Plastic Surgery · 26d
Cleared Jul 21, 2003
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)
K031085
Gyrus Medical, Inc.
General & Plastic Surgery · 108d
Cleared Jul 21, 2003
CARDIOVATIONS OPTICAL BIPOLAR DEVICE
K031846
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jul 17, 2003
UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED
K030158
Walsh Medical Devices, Inc.
General & Plastic Surgery · 182d
Cleared Jul 17, 2003
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
K031247
Medtronic Vascular
General & Plastic Surgery · 90d
Cleared Jul 17, 2003
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)
K031926
Rita Medical Systems, Inc.
General & Plastic Surgery · 24d
Cleared Jul 17, 2003
BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD
K031950
Baylis Medical Co., Inc.
General & Plastic Surgery · 23d
Cleared Jul 03, 2003
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS
K031133
Surgrx, Inc.
General & Plastic Surgery · 85d
Cleared Jun 20, 2003
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
K031675
Smith & Nephew, Inc.
General & Plastic Surgery · 21d
Cleared Jun 03, 2003
ULTRABLATOR ELECTRODE
K030720
Linvatec Corp.
General & Plastic Surgery · 88d
Cleared May 30, 2003
MSI SA ELECTRODES
K030996
Medsphere International, Inc.
General & Plastic Surgery · 60d
Cleared May 29, 2003
LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
K031011
Valleylab, Inc.
General & Plastic Surgery · 59d
Cleared May 23, 2003
SAPHYRE BIPOLAR ABLATION PROBES
K031371
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared May 22, 2003
CODMAN ISOCOOL BIPOLAR FORCEPS
K023566
Codman & Shurtleff, Inc.
General & Plastic Surgery · 211d
Cleared May 22, 2003
THERMACOOL TC SYSTEM
K031046
Thermage, Inc.
General & Plastic Surgery · 50d
Cleared May 21, 2003
EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE
K031079
Gyrus Medical, Inc.
General & Plastic Surgery · 47d
Cleared May 21, 2003
EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
K031081
Gyrus Medical, Inc.
General & Plastic Surgery · 47d
Cleared May 21, 2003
EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK
K031082
Gyrus Medical, Inc.
General & Plastic Surgery · 47d
Cleared May 19, 2003
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
K031285
Megadyne Medical Products, Inc.
General & Plastic Surgery · 26d
Cleared May 16, 2003
EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS
K031078
Gyrus Medical, Inc.
General & Plastic Surgery · 42d