Clearance Summary
ASPIRATING AND IRRIGATING CYSTS NEEDLES received FDA 510(k) clearance under submission number K885283, sponsored by Go Medical Industries Pty. , 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 1989-03-22.
- Submission: K885283
- Applicant / Sponsor: Go Medical Industries Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1989-03-22
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.