Clearance Summary
ACUFEX DOUBLE ARMED SUTURE NEEDLE received FDA 510(k) clearance under submission number K970416, sponsored by Smith & Nephew Endoscopy, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1997-04-21.
- Submission: K970416
- Applicant / Sponsor: Smith & Nephew Endoscopy, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 1997-04-21
Classification & Regulation
This clearance is catalogued under FDA product code GAT and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.