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

Caesarea Northern, IL

ICECURE MEDICAL LTD. appears in FDA device records in Caesarea Northern, IL. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 5 510(k) clearances for Icecure Medical Ltd between 2010 and 2026. The busiest year on record is 2010, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Icecure Medical Ltd, by decision year
YearClearances
20101
20191
20241
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260377XSense Cryoablation System with CryoProbesGEHSubstantially Equivalent
DEN220077ProSense™ SystemQXWUnknown
K240892XSense Cryoablation System with CryoprobesGEHSubstantially Equivalent
K183213IceSense 3, ProSense, MultiSenseGEHSubstantially Equivalent
K102360ICESENCE 3GEHSubstantially Equivalent

Registered establishments

FDA registered establishments for Icecure Medical Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087979593008797959ICECURE MEDICAL LTD.7 HaEshel street, POB 3163, Caesarea Northern 3079504 IL2026
30091349063009134906ICECURE MEDICAL, INC.39 Parker, Irvine, CA 92618 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2650-2023IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain