Clearance Summary
ANDORATE® Valve Kit received FDA 510(k) clearance under submission number K232118, sponsored by Ga Health Company 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 2023-10-16.
- Submission: K232118
- Applicant / Sponsor: Ga Health Company Limited
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-10-16
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.