Clearance Summary
ECHO-COAT ULTRASOUND NEEDLES received FDA 510(k) clearance under submission number K983647, sponsored by Sts Biopolymers. 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 1999-01-20.
- Submission: K983647
- Applicant / Sponsor: Sts Biopolymers
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1999-01-20
Classification & Regulation
This clearance is catalogued under FDA product code MJG and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.