Cleared Traditional

XSense Cryoablation System with Cryoprobes

K240892 · IceCure Medical , Ltd. · General & Plastic Surgery
Jun 2024
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K240892 is an FDA 510(k) clearance for the XSense Cryoablation System with Cryoprobes, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by IceCure Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on June 28, 2024, 88 days after receiving the submission on April 1, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K240892 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2024
Decision Date June 28, 2024
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GEH — Unit, Cryosurgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4350

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