Clearance Summary
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX received FDA 510(k) clearance under submission number K983200, sponsored by Ximed/Prosure/Injectx. 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 1998-12-11.
- Submission: K983200
- Applicant / Sponsor: Ximed/Prosure/Injectx
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1998-12-11
Classification & Regulation
This clearance is catalogued under FDA product code GAA and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.