Clearance Summary
DENVER PLEURO-PERITONEAL SHUNT received FDA 510(k) clearance under submission number K880570, sponsored by Codman & Shurtleff, 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 1988-06-20.
- Submission: K880570
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5955
- Decision date: 1988-06-20
Classification & Regulation
This clearance is catalogued under FDA product code KPM and 21 CFR 876.5955, within the Gastroenterology, Urology review panel as a Class II device.