# K011040: Cryocare Cardiac Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Jun 15, 2001 after 71 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- 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
No predicates in its family tree.
104 later devices descend from it; 5 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880 (2002), 102 descendants of its own
- K013873: Cobra Cardiac Electrosurgical System (2002), 61 descendants of its own
- K023288: Cobra Bipolar Clamp, Model 15902 (2003), 46 descendants of its own
- K021010: Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE (2002), 43 descendants of its own
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own

Source page: https://510kreport.com/device/K011040
Methodology: https://510kreport.com/methodology