# K110439: Domain Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Domain Surgical, Inc.
- Decided: Jul 18, 2011 after 153 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). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 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 1.
- K844403: Model Force 2 Electrosurgical Generator, Valleylab, Inc. (1985) Summary page 1.

## Most influential descendants
- 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
- K142229: Laparoscopic FMsealer (2015), 0 descendants of its own
- K140384: Fmwand Handpiece SE (2014), 0 descendants of its own

## Indications for use
The Domain Surgical System is indicated for cutting and coagulation of soft tissue.

Source page: https://510kreport.com/device/K110439
Methodology: https://510kreport.com/methodology