Clearance Summary
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER received FDA 510(k) clearance under submission number K944946, sponsored by U.S. Medical Products, 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 1995-02-01.
- Submission: K944946
- Applicant / Sponsor: U.S. Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1995-02-01
Classification & Regulation
This clearance is catalogued under FDA product code HWE and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.