# K973686: Endocare Cryocare Cryosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Dec 22, 1997 after 87 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: 2 generations back to K942299 (1995). 3 ancestors in all.
94 later devices descend from it; 1 cites it directly.
0 of 98 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.
- K963826: Endocare Crycare Cryosurgical System, Endocare, Inc. (1996) Summary page 1.
- K960387: Urosprobe System, Model 1000, Uros Corp. (1996) Summary page 1.

## Most influential descendants
- 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
- K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System (2003), 34 descendants of its own

## Indications for use
The ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate, kidney, and breast tissue, liver metastases, tumors, skin lesions, and warts.

Source page: https://510kreport.com/device/K973686
Methodology: https://510kreport.com/methodology