510(k) K962474
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