Clearance Summary
NATIONAL-STANDARD NEEDLE HOLDER received FDA 510(k) clearance under submission number K881956, sponsored by N-S Medical Products. 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 1988-05-20.
- Submission: K881956
- Applicant / Sponsor: N-S Medical Products
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1988-05-20
Classification & Regulation
This clearance is catalogued under FDA product code KNW and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.