510(k) K871978
K871978 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CODMAN FLEXIBLE ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on August 25, 1987. The device falls under product code GCQ (Endoscope, Flexible), a Class II device regulated under 21 CFR 876.1500. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1987
- Date Received
- May 22, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Flexible
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type