Clearance Summary
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP received FDA 510(k) clearance under submission number K012124, sponsored by Johnson & Johnson Medical (China) , 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 2001-09-19.
- Submission: K012124
- Applicant / Sponsor: Johnson & Johnson Medical (China) , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5030
- Decision date: 2001-09-19
Classification & Regulation
This clearance is catalogued under FDA product code GAP and 21 CFR 878.5030, within the General, Plastic Surgery review panel as a Class II device.