Galil Medical , Ltd.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Galil Medical , Ltd.” (first 1998, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 54 days. Since 2017 the median was 28 days, against 112 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 | 2 | 99 |
| 2013 | 1 | 51 |
| 2014 | 2 | 26 |
| 2015 | 2 | 54 |
| 2016 | 1 | 22 |
| 2017 | 1 | 54 |
| 2018 | 2 | 21 |
| 2019 | 0 | — |
| 2020 | 2 | 103 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Galil Medical , Ltd. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 29 | 29 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| NEY | System, Ablation, Microwave And Accessories | 1 | 1 |
Review panels
Most recent Galil Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203032 | IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle | GEH | 2020-11-02 | 28 |
| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) | NEY | 2020-07-09 | 178 |
| K181741 | IceSphere 1.5 CX Cryoablation Needle | GEH | 2018-07-30 | 28 |
| K181153 | ICEfx Cryoablation System | GEH | 2018-05-15 | 14 |
| K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel | GEH | 2017-11-21 | 54 |
| K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX L | GEH | 2016-10-11 | 22 |
| K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System | GEH | 2015-08-28 | 28 |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | GEH | 2015-03-05 | 79 |
| K141485 | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE | GEH | 2014-07-02 | 27 |
| K140584 | ICEROD CX CRYOABLATION NEEDLE | GEH | 2014-03-31 | 24 |
21 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2019-10-25.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Galil Medical , Ltd.?
FDA lists 31 510(k) clearances under the applicant name “Galil Medical , Ltd.” (first 1998, latest 2020), across 3 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 Galil Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Galil Medical , Ltd. is 54 days. Since 2017: 28 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Galil Medical , Ltd.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 29); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); NEY (System, Ablation, Microwave And Accessories, 1).
Next steps
- See all 31 Galil Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Galil 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.