Clearance Summary
iSurg received FDA 510(k) clearance under submission number K170054, sponsored by Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2017-10-02.
- Submission: K170054
- Applicant / Sponsor: Jaco, LLC Dba Macan Manufacturing and Bna Burz North America
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2017-10-02
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.