IceCure Medical , Ltd.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “IceCure Medical , Ltd.” (first 2010, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 95 days. Since 2017 the median was 88 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 396 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 88 |
| 2025 | 0 | — |
| 2026 | 1 | 19 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name IceCure Medical , Ltd. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 4 | 4 |
| QXW | Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer | 1 | 0 |
Review panels
Most recent IceCure Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260377 | XSense Cryoablation System with CryoProbes | GEH | 2026-02-24 | 19 |
| K240892 | XSense Cryoablation System with Cryoprobes | GEH | 2024-06-28 | 88 |
| K183213 | IceSense 3, ProSense, MultiSense | GEH | 2019-12-20 | 396 |
| K102360 | ICESENCE 3 | GEH | 2010-11-29 | 102 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220077 | De Novo | Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer | 2025-10-03 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-09-16.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named IceCure Medical , Ltd. is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT02200705: Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial (Completed, started 2014-10)
- NCT02399124: Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma (Active not recruiting, started 2014-07)
- NCT01671943: Cryotherapy for Breast Cancer Trial (Completed, started 2012-08)
- NCT00910312: ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial (Completed, started 2009-04)
SEC filings
IceCure Medical Ltd. (ICCM): EDGAR filings, CIK 1584371. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under IceCure Medical , Ltd.?
FDA lists 4 510(k) clearances under the applicant name “IceCure Medical , Ltd.” (first 2010, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by IceCure Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name IceCure Medical , Ltd. is 95 days. Since 2017: 88 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under IceCure Medical , Ltd.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 4); QXW (Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer, 1).
Next steps
- See all 4 IceCure Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEH, IceCure Medical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.