Clearance Summary
CODMAN FLEXIBLE ENDOSCOPE received FDA 510(k) clearance under submission number K871978, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1987-08-25.
- Submission: K871978
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1987-08-25
Classification & Regulation
This clearance is catalogued under FDA product code GCQ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.