Clearance Summary
ELECTROSURGICAL PROBES AND DEVICES-GELTX received FDA 510(k) clearance under submission number K002269, 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 2001-01-04.
- Submission: K002269
- Applicant / Sponsor: Ximed/Prosure/Injectx
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2001-01-04
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.