Clearance Summary
MODEL #53110 DISPOSABLE ANOSCOPE received FDA 510(k) clearance under submission number K810227, 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 1981-02-19.
- Submission: K810227
- Applicant / Sponsor: Welch Allyn, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1981-02-19
Classification & Regulation
This clearance is catalogued under FDA product code FER and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.