510(k) K902658

GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES by Gynescope Corp. — Product Code KNF

K902658 is an FDA 510(k) premarket notification submitted by Gynescope Corp. for the device "GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES". The FDA issued a decision of Substantially Equivalent on September 19, 1990. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Gynescope Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1990
Date Received
June 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type