Clearance Summary
SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 received FDA 510(k) clearance under submission number K892667, 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: K892667
- 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 FKN and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.