# K061544: Stellartech 100 Coagulation System

- Pathway: 510(k) (Traditional)
- Applicant: Stellartech Research Corp.
- Decided: Oct 13, 2006 after 130 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: 8 generations back to K942299 (1995). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 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.
- K023765: Stellartech Coagulation System (Models 1100C-115 & 1100C-230), Stellartech Research Corp. (2002) Summary page 1.
- K974521: Vnus Closure System, Vnus Medical Technologies, Inc. (1998) Summary page 1.
- K032062: Stellartech Coagulation System, Models  (1100C-115 & 1100C-230), Stellartech Research Corp. (2003) Summary page 1.
- K981981: Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt) Model 4811, Instrument Cable, 19, Boston Scientific Corp (1998) Summary page 1.
- K970278: Microvasive Gold Probe, Boston Scientific Corp (1997) Summary page 1.
- K060484: Erbe Vio Esu, Model Vio 300 D, Erbe USA, Inc. (2006) Summary page 1.
- K060400: Cardioblate Surgical  Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation Device, Model 60831; Cardioblat, Medtronic, Inc. (2006) Summary page 1.
- K052203: Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600, Kirwan Surgical Products, Inc. (2005) Summary page 1.
- K051749: Cobra Surgical System, Estech, Inc. (2005) Summary page 1.
- K011722: Atricure Bipolar Coagulation System, AtriCure, Inc. (2001) Summary page 1.

## Indications for use
The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

Source page: https://510kreport.com/device/K061544
Methodology: https://510kreport.com/methodology