Clearance Summary
DISPOS-A-SCOPE received FDA 510(k) clearance under submission number K993738, sponsored by Dispos-A-Scope. 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 2000-01-06.
- Submission: K993738
- Applicant / Sponsor: Dispos-A-Scope
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2000-01-06
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.