Cleared Special

K260377 - XSense Cryoablation System with CryoProbes (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260377 · IceCure Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
19d
Days
Class 2
Risk

K260377 is an FDA 510(k) clearance for the XSense Cryoablation System with CryoProbes. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by IceCure Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on February 24, 2026 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all IceCure Medical , Ltd. devices

Submission Details

510(k) Number K260377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2026
Decision Date February 24, 2026
Days to Decision 19 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 114d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 260
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K260377.
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