Clearance Summary
SELF RETAINING SOFT TISSUE RETRACTOR received FDA 510(k) clearance under submission number K101609, sponsored by Koros USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-12-09.
- Submission: K101609
- Applicant / Sponsor: Koros USA, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 2010-12-09
Classification & Regulation
This clearance is catalogued under FDA product code LXH and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.