Clearance Summary
TENCKHOFF CATHETER received FDA 510(k) clearance under submission number K801818, sponsored by Sil-Med Corp.. 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 1980-10-23.
- Submission: K801818
- Applicant / Sponsor: Sil-Med Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1980-10-23
Classification & Regulation
This clearance is catalogued under FDA product code FJS and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.