Clearance Summary
SURGITEK NEPHROSTENT KIT received FDA 510(k) clearance under submission number K831446, sponsored by Mec/Surgitek Products. 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 1983-06-22.
- Submission: K831446
- Applicant / Sponsor: Mec/Surgitek Products
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4620
- Decision date: 1983-06-22
Classification & Regulation
This clearance is catalogued under FDA product code FAD and 21 CFR 876.4620, within the Gastroenterology, Urology review panel as a Class II device.