Clearance Summary
BURS FOR MICRO SURGICAL DRILL SYSTEM received FDA 510(k) clearance under submission number K853658, sponsored by Acumed Instruments Corp.. 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 1985-09-24.
- Submission: K853658
- Applicant / Sponsor: Acumed Instruments Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1985-09-24
Classification & Regulation
This clearance is catalogued under FDA product code GFF and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.