# K050831: Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A

- Pathway: 510(k) (Special)
- Applicant: Stellartech Research Corp.
- Decided: Apr 12, 2005 after 11 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: 12 generations back to K943450 (1995). 29 ancestors in all.
34 later devices descend from it; 5 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013139: Stellartech Coagulation System, Stellartech Research Corp. (2001) Summary page 1.
- K023765: Stellartech Coagulation System (Models 1100C-115 & 1100C-230), Stellartech Research Corp. (2002) Summary page 1.
- K032062: Stellartech Coagulation System, Models  (1100C-115 & 1100C-230), Stellartech Research Corp. (2003) Summary page 2.
- K032452: Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230, Stellartech Research Corp. (2003) Summary page 1.
- K032721: Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230), Stellartech Research Corp. (2003) Summary page 1.
- K040240: Stellartech Coagulation System (Models 1100C-115 & 1100C-230), Stellartech Research Corp. (2004) Summary page 1.
- K041383: Stellartech Coagulation System, Models 1100C-115 and 1100C-230, Stellartech Research Corp. (2004) Summary page 5.
- K042909: Stellartech Coagulation System, Models 1100C-115A & 1100C-230A, Stellartech Research Corp. (2004) Summary page 1.

## Most influential descendants
- K060169: Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F (2006), 29 descendants of its own
- K062723: HALO90 Coagulation Catheter (2006), 26 descendants of its own
- K083737: Halo Ablation Catheter (2009), 22 descendants of its own
- K062225: Halo Coagulation Catheter (2006), 20 descendants of its own
- K071543: HALO360' Coagulation Catheter (2007), 19 descendants of its own

## Indications for use
The Stellartech Coagulation System 2 is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Source page: https://510kreport.com/device/K050831
Methodology: https://510kreport.com/methodology