# IceCure Medical, Ltd.

- Location (FDA's records): Caesarea, IL
- FDA decisions: 5 (2010–2026): 4 510(k) clearances and 1 De Novo grant
- Names in FDA's records: IceCure Medical , Ltd. (4); Icecure Medical (1)
- Product codes: GEH (4), QXW (1)
- 510(k) review time since 2016: median 88 days, against 115 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Galil Medical, Ltd.: 2 (https://510kreport.com/company/galil-medical)
- Arbel Medical, Ltd.: 1 (https://510kreport.com/company/arbel-medical)
- Sanarus Medical, Inc.: 1 (https://510kreport.com/company/sanarus-medical)

## Firms that cite its devices most
- CSA Medical, Inc.: 1 (https://510kreport.com/company/csa-medical)
- Hygea Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/hygea-medical-technology)

## Its most-cited devices
- K102360: Icesence 3 (2010), cited by 2
- K240892: XSense Cryoablation System with Cryoprobes (2024), cited by 2
- K183213: IceSense 3, ProSense, MultiSense (2019), cited by 1

## Recent decisions
- K260377: XSense Cryoablation System with CryoProbes (Feb 24, 2026)
- DEN220077: ProSense™ System (Oct 3, 2025)
- K240892: XSense Cryoablation System with Cryoprobes (Jun 28, 2024)
- K183213: IceSense 3, ProSense, MultiSense (Dec 20, 2019)
- K102360: Icesence 3 (Nov 29, 2010)

Source page: https://510kreport.com/company/icecure-medical