# K011074: Cryocare Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Jan 25, 2002 after 291 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
56 later devices descend from it; 3 cite it directly.
0 of 57 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
- K023757: Cryocare Surgical System, Model Cryo 20 (2002), 54 descendants of its own
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140 (2010), 39 descendants of its own
- K113237: Certus 140 2.45GHZ Ablation System (2012), 38 descendants of its own
- K133821: Emprint Ablation System (2014), 29 descendants of its own
- K163105: Emprint Ablation System (2016), 13 descendants of its own

## Recalls of this device
- Dec 5, 2008 · Not classified · Z-1401-2010: Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes 
- Dec 5, 2008 · Not classified · Z-1400-2010: Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes 

Source page: https://510kreport.com/device/K011074
Methodology: https://510kreport.com/methodology