# K230271: ISOLIS Cryoprobe

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Mar 28, 2023 after 56 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: 12 generations back to K926514 (1993). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201588: CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice, Varian Medical Systems, Inc. (2020) Summary page 5.

## Most influential descendants
- K243042: Co-Ablation System with Sterile Co-Ablation Probe (2025), 0 descendants of its own

## Indications for use
The ISOLIS cryoprobes, used with the Cryocare Systems, are intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The systems are designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the systems are intended for use in the following indications: General Surgery • Destruction of warts or lesions • Palliation of tumors of the oral cavity, rectum and skin • Ablation of breast fibroadenomas • Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions Urology • Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Gynecology • Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology • Ablation of cancerous or malignant tissue • Ablation of benign tumors • Palliative intervention Neurology • Freezing of nerve tissue in pain management/cryoanalgesia Dermatology • Ablation or freezing of skin cancers and other cutaneous disorders Proctology • Ablation of benign or malignant growths of the anus or rectum • Ablation of hemorrhoids Thoracic Surgery • Ablation of cancerous lesions

Source page: https://510kreport.com/device/K230271
Methodology: https://510kreport.com/methodology