# K980110: Endocre Cryocare Cryosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Apr 10, 1998 after 88 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: 3 generations back to K942299 (1995). 5 ancestors in all.
93 later devices descend from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973190: Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series, Cryomedical Sciences, Inc. (1997) Summary page 2.
- K973686: Endocare Cryocare Cryosurgical System, Endocare, Inc. (1997) Summary page 2.

## Most influential descendants
- 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
- K022894: Epicor Medical Ablation System (2004), 23 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 ta destroy tissue by the application of extreme cold temperatures including, prostate, and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intcnded for use in the following indications: Urology Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Oncology Ablation of cancerous or malignant tissue Ablation of benign tumors Palliative intervention Dermatology Ablation or freezing of skin cancers and other cutaneous disorders Gynecology Ablation of malignant neoplasia or benign dysplasia of the female geniralia General Surgery Destruction of warts or lesions Palliation of tumors of the oral cavity, rectum and skin Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus arca, ulcerated basal cell tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions Thoracic Surgery Ablation of arrhythmic cardiac tissue Ablation of cancerous lesions Proctology Ablation of benign or malignant growths of the anus or rcctum Ablation of hemorrhoids

Source page: https://510kreport.com/device/K980110
Methodology: https://510kreport.com/methodology