# K023291: Cobra Cooled Cardiac Surgical Probe, Model 1596X

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Oct 17, 2002 after 15 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: 1 generation back to K981981 (1998). 2 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981981: Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt) Model 4811, Instrument Cable, 19, Boston Scientific Corp (1998) Summary page 2.
- K010956: Cobra 1/2 Flex Surgical Probe, Model 1593X; Cobra Flex Surgical Probe Model 1594X, Boston Scientific Corp (2001)

## Most influential descendants
- 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
- K110117: Atricure Bipolar System (2011), 5 descendants of its own

## Indications for use
The CobraB Cardiac Surgical Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.

Source page: https://510kreport.com/device/K023291
Methodology: https://510kreport.com/methodology