MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System— 510(k) K233185

Substantially Equivalent

C2dx, Inc.

FDA 510(k) clearance K233185 for MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System, Substantially Equivalent on 2023-10-24. Applicant: C2dx, Inc..

Clearance details

Applicant: C2dx, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2023-09-28
Decision date: 2023-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Schoolcraft, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.