Clearance Summary
CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE received FDA 510(k) clearance under submission number K862481, sponsored by CIVCO Medical Instruments Co., 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 1986-07-23.
- Submission: K862481
- Applicant / Sponsor: CIVCO Medical Instruments Co., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1986-07-23
Classification & Regulation
This clearance is catalogued under FDA product code GDM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.