510(k) K902657

GYNESCOPE LAPAROSCOPIC FORCEPS by Gynescope Corp. — Product Code HET

K902657 is an FDA 510(k) premarket notification submitted by Gynescope Corp. for the device "GYNESCOPE LAPAROSCOPIC FORCEPS". The FDA issued a decision of Substantially Equivalent on September 19, 1990. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. 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
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type