# K121881: Domain Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Domain Surgical, Inc.
- Decided: Oct 18, 2012 after 114 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933157 (1994). 24 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110439: Domain Surgical System, Domain Surgical, Inc. (2011) Summary page 1.
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices, Peak Surgical, Inc. (2008) Summary page 2.

## Most influential descendants
- 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 during surgical procedures, including Gynecologic procedures (open transabdominal only).

Source page: https://510kreport.com/device/K121881
Methodology: https://510kreport.com/methodology