K233185
- 510(k) number
- K233185
- Device name
- MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System
- Applicant
- C2dx, Inc. MI · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2023-10-24
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233185.pdf
Official FDA record: K233185
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.