Clearance Summary
O'REGAN DISPOSABLE ANOSCOPE received FDA 510(k) clearance under submission number K020702, sponsored by Canadian Theatre Products , Ltd.. 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 2002-03-29.
- Submission: K020702
- Applicant / Sponsor: Canadian Theatre Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2002-03-29
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.