Clearance Summary
BeneHold Surgical Incise Drape with CHG antimicrobial received FDA 510(k) clearance under submission number K202208, sponsored by Avery Dennison Belgie Bvba. 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 2021-07-30.
- Submission: K202208
- Applicant / Sponsor: Avery Dennison Belgie Bvba
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2021-07-30
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.