Clearance Summary
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture received FDA 510(k) clearance under submission number K203081, sponsored by Lsi Solutions. 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 2020-11-24.
- Submission: K203081
- Applicant / Sponsor: Lsi Solutions
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 2020-11-24
Classification & Regulation
This clearance is catalogued under FDA product code GAS and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.