Clearance Summary
WATERS ILEAL RESERVOIR CATHETER received FDA 510(k) clearance under submission number K813494, sponsored by Waters Instruments, 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 1981-12-31.
- Submission: K813494
- Applicant / Sponsor: Waters Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5030
- Decision date: 1981-12-31
Classification & Regulation
This clearance is catalogued under FDA product code KPH and 21 CFR 876.5030, within the Gastroenterology, Urology review panel as a Class I device.