Clearance Summary
MANAN V.S. ACCESS NEEDLE/SET received FDA 510(k) clearance under submission number K963767, sponsored by Manan 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 1997-05-16.
- Submission: K963767
- Applicant / Sponsor: Manan Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 1997-05-16
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.