Clearance Summary
MULTIPLE MANUAL SURGICAL INSTRUMENTS received FDA 510(k) clearance under submission number K832686, sponsored by Hirata Sangyo Co. 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 1983-10-14.
- Submission: K832686
- Applicant / Sponsor: Hirata Sangyo Co. USA, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1983-10-14
Classification & Regulation
This clearance is catalogued under FDA product code HTO and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.