Clearance Summary
MICROPERFORATION INSTRUMENT received FDA 510(k) clearance under submission number K001507, sponsored by Smith & Nephew, 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 2000-06-14.
- Submission: K001507
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 2000-06-14
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.