Clearance Summary
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) received FDA 510(k) clearance under submission number K895408, sponsored by Smith & Nephew United, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1989-12-14.
- Submission: K895408
- Applicant / Sponsor: Smith & Nephew United, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1989-12-14
Classification & Regulation
This clearance is catalogued under FDA product code KGX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.