Clearance Summary
CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) received FDA 510(k) clearance under submission number K920979, 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 1993-03-23.
- Submission: K920979
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1993-03-23
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.