Last synced on 25 January 2026 at 3:41 am

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233185
510(k) Type
Special
Applicant
C2dx, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/24/2023
Days to Decision
26 days
Submission Type
Summary

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233185
510(k) Type
Special
Applicant
C2dx, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/24/2023
Days to Decision
26 days
Submission Type
Summary