Clearance Summary
BIOPSY NEEDLE GUIDE KIT, STERILE received FDA 510(k) clearance under submission number K871503, sponsored by Amedic USA. 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 1987-07-10.
- Submission: K871503
- Applicant / Sponsor: Amedic USA
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1987-07-10
Classification & Regulation
This clearance is catalogued under FDA product code FZX and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.