Clearance Summary
STAMEY NEEDLE received FDA 510(k) clearance under submission number K884553, sponsored by Cook Ob/Gyn. 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 1988-11-14.
- Submission: K884553
- Applicant / Sponsor: Cook Ob/Gyn
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1988-11-14
Classification & Regulation
This clearance is catalogued under FDA product code GEJ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.