Clearance Summary
BREAST LESION LOCALIZATION NEEDLE received FDA 510(k) clearance under submission number K944942, sponsored by Promedical , Ltd.. 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 1994-11-04.
- Submission: K944942
- Applicant / Sponsor: Promedical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1994-11-04
Classification & Regulation
This clearance is catalogued under FDA product code GDF and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.