# K033089: Hemostatix, Model 2400Z Thermal Scalpel System

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Feb 5, 2004 after 129 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Oximetrix Shaw Hemostatic Surgical System: named in the summary without a submission number

## Most influential descendants
- K091107: Model P8400 Hemostatix Thermal Scalpel System (2009), 8 descendants of its own
- K110439: Domain Surgical System (2011), 5 descendants of its own
- K121881: Domain Surgical System (2012), 4 descendants of its own
- K130606: Fmwand Ferromagnetic Surgical System (2014), 3 descendants of its own
- K141484: Open Fmsealer (2014), 1 descendant of its own

## Recalls of this device
- Jul 27, 2010 · Not classified · Z-2595-2010: Lack of sterility assurance
- Jul 27, 2010 · Not classified · Z-2596-2010: Lack of sterility assurance

## Indications for use
The Hemostatix Model 2400Z Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum 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/K033089
Methodology: https://510kreport.com/methodology