Clearance Summary
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 received FDA 510(k) clearance under submission number K030170, sponsored by Opus Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-07-28.
- Submission: K030170
- Applicant / Sponsor: Opus Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2003-07-28
Classification & Regulation
This clearance is catalogued under FDA product code OCW and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.