Clearance Summary
GORE-TEX PERITONEAL CATHETERR received FDA 510(k) clearance under submission number K820909, sponsored by W. L. Gore & Associates, 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 1982-05-21.
- Submission: K820909
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1982-05-21
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.