# K963826: Endocare Crycare Cryosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Dec 18, 1996 after 84 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- 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 K942299 (1995). 1 ancestor in all.
115 later devices descend from it; 2 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942299: Endocare Cryotherapy System, Cytocare, Inc. (1995) Summary page 1.

## Most influential descendants
- K973686: Endocare Cryocare Cryosurgical System (1997), 94 descendants of its own
- K980110: Endocre Cryocare Cryosurgical System (1998), 93 descendants of its own
- K011722: Atricure Bipolar Coagulation System (2001), 92 descendants of its own
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (2002), 90 descendants of its own
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own

## Indications for use
The ENDOcare CRYOcare™ Cryotherapy System is designed for use in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology and urology for the ablation of tissue, including liver metastases, skin lesions, warts and removal of prostate tissue.

Source page: https://510kreport.com/device/K963826
Methodology: https://510kreport.com/methodology