Clearance Summary
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) received FDA 510(k) clearance under submission number K102861, sponsored by A Plus International, 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 2011-01-13.
- Submission: K102861
- Applicant / Sponsor: A Plus International, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2011-01-13
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.