Clearance Summary
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT received FDA 510(k) clearance under submission number K100787, sponsored by Smith & Nephew, 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 2010-09-17.
- Submission: K100787
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2010-09-17
Classification & Regulation
This clearance is catalogued under FDA product code FTL and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.