Clearance Summary
BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE received FDA 510(k) clearance under submission number K010572, sponsored by Becton, Dickinson and Co.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2001-03-12.
- Submission: K010572
- Applicant / Sponsor: Becton, Dickinson and Co.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2001-03-12
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.