Clearance Summary
ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD received FDA 510(k) clearance under submission number K940299, sponsored by Debusk Technology Corp.. 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 1994-05-02.
- Submission: K940299
- Applicant / Sponsor: Debusk Technology Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1994-05-02
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.