# K013139: Stellartech Coagulation System

- Pathway: 510(k) (Traditional)
- Applicant: Stellartech Research Corp.
- Decided: Dec 18, 2001 after 90 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: 5 generations back to K943450 (1995). 20 ancestors in all.
42 later devices descend from it; 8 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994173: Stellartech Radiofrequency Generator,Model 1025A-115, Stellartech Radiofrequency Generator, Model 1025A-230, Stellartech Research Corp. (2000) Summary page 1.
- K971532: Arthrocare Electrosurgery System, Arthrocare Corp. (1997) Summary page 1.
- K981672: Radiotherapeutics RF-2000 Radiofrequency Generator, Radiotherapeutics Corp. (1998) Summary page 1.
- K943014: Balloon Electrosurgical Probes and Devices, Ximed Medical Systems (1996) Summary page 1.
- K970278: Microvasive Gold Probe, Boston Scientific Corp (1997) Summary page 1.
- K980046: Bronchial Catheter System, Broncus Technologies, Inc. (1998) Summary page 1.
- K940965: Eliminator Balloon Dilator, C.R. Bard, Inc. (1994) Summary page 1.
- K834413: Dilation Balloon Catheter, Hobbs Medical, Inc. (1984) Summary page 1.
- (no number) Boston Scientific Microvasive Rigiflex ABD Achalasia Balloon Dilator: named in the summary without a submission number

## Most influential descendants
- K032062: Stellartech Coagulation System, Models  (1100C-115 & 1100C-230) (2003), 41 descendants of its own
- K032452: Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 (2003), 39 descendants of its own
- K032721: Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) (2003), 38 descendants of its own
- K040240: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) (2004), 37 descendants of its own
- K041383: Stellartech Coagulation System, Models 1100C-115 and 1100C-230 (2004), 36 descendants of its own

## Indications for use
The Stellartech Coagulation System 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/K013139
Methodology: https://510kreport.com/methodology