# 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

- Pathway: 510(k) (Traditional)
- Applicant: Epicor Medical, Inc.
- Decided: May 5, 2004 after 56 days
- Product code: NTB (System, Ablation, Ultrasound And 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: 7 generations back to K942299 (1995). 49 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022894: Epicor Medical Ablation System, Epicor Medical, Inc. (2004) Summary page 4.
- K013873: Cobra Cardiac Electrosurgical System, Boston Scientific Corp (2002) Summary page 4.
- K023291: Cobra Cooled Cardiac Surgical Probe, Model 1596X, Boston Scientific Corp (2002) Summary page 4.
- K003978: Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007, Afx, Inc. (2001) Summary page 4.
- K013946: Flex 10 Accessory for the Afx Microwave Ablation System, Afx, Inc. (2002) Summary page 4.
- K011988: Surgical Lightstic 180, Model 180 L, Model 180 C, Cardiofocus, Inc. (2001)
- K013901: Malleable Surgical Lightstic 180, Model 180 (1CM-9CM), Cardiofocus, Inc. (2001) Summary page 4.

## Cited in the summary but kept off the family tree
- K031392: Mas Tox Ammonia Controlliquid Assayed Tox Ammonia Control, Medical Analysis Systems, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K110117: Atricure Bipolar System (2011), 5 descendants of its own
- K093203: Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841 (2010), 3 descendants of its own

## Indications for use
The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery. The items in the UltraCinch Accessory Pack are intended for use in the ablation of cardiac tissue during cardiac surgery.

Source page: https://510kreport.com/device/K040641
Methodology: https://510kreport.com/methodology