Clearance Summary
TROTEX II SCREW NEEDLE BIOPSY INSTR. SET received FDA 510(k) clearance under submission number K792316, sponsored by Ursus Konsult AB. 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 1979-12-18.
- Submission: K792316
- Applicant / Sponsor: Ursus Konsult AB
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1979-12-18
Classification & Regulation
This clearance is catalogued under FDA product code GEE and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.