Clearance Summary
ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC received FDA 510(k) clearance under submission number K061878, sponsored by E Surgical, LLC. 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 2006-10-24.
- Submission: K061878
- Applicant / Sponsor: E Surgical, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2006-10-24
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.