Clearance Summary
Disposable Endoscope Valve Sets received FDA 510(k) clearance under submission number K220884, sponsored by Sml Med-Tech Solutions Limited. 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 2023-01-17.
- Submission: K220884
- Applicant / Sponsor: Sml Med-Tech Solutions Limited
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-01-17
Classification & Regulation
This clearance is catalogued under FDA product code ODC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.