Clearance Summary
BOWEN SUTURE PASSER received FDA 510(k) clearance under submission number K863146, sponsored by Bowen & Company, 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 1986-09-05.
- Submission: K863146
- Applicant / Sponsor: Bowen & Company, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1986-09-05
Classification & Regulation
This clearance is catalogued under FDA product code HXI and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.