510(k) K770943
K770943 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "ENDOSCOPE, UROLOGICAL, FEMALE". The FDA issued a decision of Substantially Equivalent on October 18, 1977. The device falls under product code FAL (Panendoscope (Urethroscope)), a Class II device regulated under 21 CFR 876.1500. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1977
- Date Received
- May 25, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Panendoscope (Urethroscope)
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type