Clearance Summary
Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories received FDA 510(k) clearance under submission number K192124, sponsored by Us Medical Innovations, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-11-21.
- Submission: K192124
- Applicant / Sponsor: Us Medical Innovations, LLC
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2019-11-21
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.