Clearance Summary
S-100 ALLEN-BROWN SHUNT received FDA 510(k) clearance under submission number K892663, sponsored by Akcess 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 1989-05-04.
- Submission: K892663
- Applicant / Sponsor: Akcess Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1989-05-04
Classification & Regulation
This clearance is catalogued under FDA product code FIQ and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.