510(k) K941992
K941992 is an FDA 510(k) premarket notification submitted by Surgical Technologies, Inc. for the device "CYSTOSCOPE". The FDA issued a decision of Substantially Equivalent on November 30, 1995. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Surgical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1995
- Date Received
- April 25, 1994
- 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