Clearance Summary
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN received FDA 510(k) clearance under submission number K123409, sponsored by Surgical Specialties Corp. Dba Angiotech. 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 2012-11-20.
- Submission: K123409
- Applicant / Sponsor: Surgical Specialties Corp. Dba Angiotech
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4493
- Decision date: 2012-11-20
Classification & Regulation
This clearance is catalogued under FDA product code GAM and 21 CFR 878.4493, within the General, Plastic Surgery review panel as a Class II device.