← Back to catalogue

CRYOCARE Touch System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201588

by Varian Medical Systems, Inc.

Identifiers

510(k) Number
K201588 FDA 510(k)
FDA Product Code
GEH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4350 FDA 510(k)
Regulation Number
878.4350 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Endocare 1.7mm Round Ice PerCryo Cryoprobe is a cryosurgical probe designed for controlled tissue freezing, classified as a Unit, Cryosurgical, Accessory. It delivers precise cryoablation by generating ice formation within targeted tissues, enabling minimally invasive treatment for conditions requiring localized cold therapy, such as benign tumors or vascular malformations.

This device is part of the CRYOCARE Touch System, supplied as a reusable or single-use accessory depending on the probe variant. It is intended for use in sterile surgical settings, with the 1.7mm diameter probe optimized for endocavitary or minimally invasive procedures. The system has received FDA 510(k) clearance under the Traditional pathway (K201588) and MDR authorization, adhering to regulatory standards for Class II medical devices (product code GEH). Storage and handling follow manufacturer guidelines to maintain sterility and functionality.

Frequently asked questions

What types of procedures is the 1.7mm Round Ice PerCryo Cryoprobe designed for, and how does its size make it suitable for those applications?

The 1.7mm Round Ice PerCryo Cryoprobe is specifically designed for endocavitary or minimally invasive procedures, where precise tissue freezing is required. Its small diameter (1.7mm) allows it to be inserted into confined or delicate anatomical spaces, such as internal cavities or vascular malformations, enabling targeted cryoablation without excessive tissue disruption. This makes it ideal for treating localized conditions like benign tumors where minimally invasive techniques are preferred.

Is the Endocare 1.7mm Round Ice PerCryo Cryoprobe single-use or reusable, and how should it be handled to maintain sterility?

The Endocare 1.7mm Round Ice PerCryo Cryoprobe is supplied as part of the CRYOCARE Touch System, which includes both reusable and single-use variants depending on the specific probe variant. For sterility, it must be used in sterile surgical settings as outlined by the manufacturer. Handling instructions emphasize proper storage, packaging integrity, and adherence to sterile techniques to ensure functionality and safety before and during use.

What regulatory pathways has the CRYOCARE Touch System and its accessories undergone, and what does this mean for clinicians or buyers?

The CRYOCARE Touch System, including the Endocare 1.7mm Round Ice PerCryo Cryoprobe, has received FDA 510(k) clearance under the Traditional pathway (K201588) and MDR authorization, confirming compliance with regulatory standards for Class II medical devices (product code GEH). This means the device has been evaluated for safety and effectiveness by the FDA and meets European Union medical device regulations, providing assurance of its quality and suitability for clinical use in both markets.

How does the cryoprobe’s design support controlled tissue freezing, and what types of tissues or conditions is it intended to treat?

The Endocare 1.7mm Round Ice PerCryo Cryoprobe delivers controlled tissue freezing by generating ice formation within targeted tissues, enabling precise cryoablation. This is particularly useful for treating benign tumors or vascular malformations where localized cold therapy is required. Its design allows for minimally invasive access, reducing trauma while achieving effective ablation of the targeted tissue.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo ..., K201588 FDA 510 (k) - CRYOCARE TOUCH System and Accessories, CRYOCARE TOUCH System And Accessories, Endocare… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Varian Medical Systems, Inc.

Sources (2)

  • FDA 510(k) K201588 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026