510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220077Unknown

ProSense™ System

Icecure Medical Ltd, Caesarea, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN220077 is the FDA 510(k) clearance record for ProSense™ System, a class II device, cleared for Icecure Medical on under FDA product code QXW (Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer). FDA's definition for product code QXW reads: "A cryoablation device for local treatment of low-risk breast cancer is a prescription device that uses cold temperatures to destroy a breast tumor and its surrounding tissue. The device is intended as a local treatment and may be used with...". FDA records list 5 510(k) clearances for Icecure Medical, from to . As of , FDA records show no recalls naming DEN220077.

Clearance record

Decision date
Received
(1,080 days to decision)
Product code
QXW Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer
Regulation
21 CFR 878.4355
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Icecure Medical 7 Ha`Eshel St., P.O. Box 3163, Caesarea, IL
Third party review
No

Clearances, product code QXW

Trailing 12 months

FDA records hold no clearances under product code QXW in the trailing twelve months.

FDA records show no clearances under product code QXW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260