Clearance Summary
MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System received FDA 510(k) clearance under submission number K233185, sponsored by C2dx, Inc.. 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 2023-10-24.
- Submission: K233185
- Applicant / Sponsor: C2dx, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2023-10-24
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.