# K233185: MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

- Pathway: 510(k) (Special)
- Applicant: C2dx, Inc.
- Decided: Oct 24, 2023 after 26 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033089 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091107: Model P8400 Hemostatix Thermal Scalpel System, Hemostatix Medical Technologies, LLC (2009) Summary page 5.

## Indications for use
The Shaw Scalpel System Controller (Model SG6) is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional stainless steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated temperature blade.

Source page: https://510kreport.com/device/K233185
Methodology: https://510kreport.com/methodology