Clearance Summary
TUCK-TITE COLON FLUID RETAINER received FDA 510(k) clearance under submission number K833860, sponsored by Clayton Medical Products, Inc.. 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 1983-12-27.
- Submission: K833860
- Applicant / Sponsor: Clayton Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5210
- Decision date: 1983-12-27
Classification & Regulation
This clearance is catalogued under FDA product code FCE and 21 CFR 876.5210, within the Gastroenterology, Urology review panel as a Class I device.