# K013901: Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)

- Pathway: 510(k) (Special)
- Applicant: Cardiofocus, Inc.
- Decided: Dec 20, 2001 after 24 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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 K980668 (1998). 3 ancestors in all.
30 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011988: Surgical Lightstic 180, Model 180 L, Model 180 C, Cardiofocus, Inc. (2001) Summary page 1.

## Most influential descendants
- K022894: Epicor Medical Ablation System (2004), 23 descendants of its own
- K040641: Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1 (2004), 22 descendants of its own
- K043579: Atricure Bipolar System (2007), 18 descendants of its own
- K080509: Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical Ablation Device (2008), 10 descendants of its own
- K101174: Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2 (2010), 6 descendants of its own

## Indications for use
Coagulation of Cardiac Tissue

Source page: https://510kreport.com/device/K013901
Methodology: https://510kreport.com/methodology