Clearance Summary
SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME received FDA 510(k) clearance under submission number K100593, sponsored by Lsi Solutions, 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 2010-10-13.
- Submission: K100593
- Applicant / Sponsor: Lsi Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5010
- Decision date: 2010-10-13
Classification & Regulation
This clearance is catalogued under FDA product code GAW and 21 CFR 878.5010, within the General, Plastic Surgery review panel as a Class II device.