Clearance Summary
BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS received FDA 510(k) clearance under submission number K945995, 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 1995-01-31.
- Submission: K945995
- 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: 1995-01-31
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.