Clearance Summary
SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 received FDA 510(k) clearance under submission number K770291, sponsored by Welch Allyn, 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 1977-02-18.
- Submission: K770291
- Applicant / Sponsor: Welch Allyn, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1977-02-18
Classification & Regulation
This clearance is catalogued under FDA product code FAM and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.