Clearance Summary
UMS-100 received FDA 510(k) clearance under submission number K853683, sponsored by Narco Bio-Systems. 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 1986-01-10.
- Submission: K853683
- Applicant / Sponsor: Narco Bio-Systems
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 1986-01-10
Classification & Regulation
This clearance is catalogued under FDA product code FAP and 21 CFR 876.1620, within the Gastroenterology, Urology review panel as a Class II device.