510(k) K962474

OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) by Olympus America, Inc. — Product Code FBO

K962474 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)". The FDA issued a decision of Substantially Equivalent on December 20, 1996. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Olympus America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1996
Date Received
June 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystourethroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type