FDA 510(k)

CUTTING AND COAGULATION DEVICES AND ACCESSORIES

K-Number: K921696 · 1992-11-18

Decision Date1992-11-18

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CUTTING AND COAGULATION DEVICES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is American Cyanamid Co.. It received FDA 510(k) clearance on 1992-11-18 under 510(k) number K921696. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUTTING AND COAGULATION DEVICES AND ACCESSORIES?

CUTTING AND COAGULATION DEVICES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1992-11-18. The listed applicant is American Cyanamid Co.. The 510(k) number is K921696.

When did CUTTING AND COAGULATION DEVICES AND ACCESSORIES receive FDA 510(k) clearance?

CUTTING AND COAGULATION DEVICES AND ACCESSORIES received FDA 510(k) clearance on 1992-11-18, under 510(k) number K921696.

Who is the listed applicant for CUTTING AND COAGULATION DEVICES AND ACCESSORIES?

The FDA 510(k) record lists American Cyanamid Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUTTING AND COAGULATION DEVICES AND ACCESSORIES?

The FDA product code for CUTTING AND COAGULATION DEVICES AND ACCESSORIES is GEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Cyanamid Co. as applicant

K930992FLEXON AND STAINLESS STEEL SUTURES K931056DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING K922348VALTRAC(R) INTRODUCER FORCEP K900198DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.K896946COATED NOVAFIL, POLYBUTESTER, MESH K823552APPOSE SKIN STAPLER & REMOVER

View all 7 devices →

Related Devices (Code: GEI)

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.