Clearance Summary
BeneHold Surgical Incise Drape with CHG antimicrobial II received FDA 510(k) clearance under submission number K230645, sponsored by Avery Dennison Medical , Ltd.. 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 2023-10-25.
- Submission: K230645
- Applicant / Sponsor: Avery Dennison Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2023-10-25
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.