Data / Medical devices / Israel / Galil Medical Ltd.
Galil Medical Ltd.: FDA-registered device maker in YOKNEAM Northern, Israel, 14 510(k) clearances
Galil Medical Ltd. is registered with the FDA (registration 9616793) in YOKNEAM Northern, Israel. It lists 2 device types. The FDA files 14 510(k) clearances under its listings, the newest dated October 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616793
- FEI number
- 3002843919
- Address
- Industrial Park, Tavor Building 1, YOKNEAM Northern, Israel, 2069203
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Manufacturer
- First device listed
- October 11, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2024 | K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | GEH | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| November 22, 2023 | K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | GEH | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| July 30, 2018 | K181741 | IceSphere 1.5 CX Cryoablation Needle | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| October 11, 2016 | K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX L | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| August 28, 2015 | 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 | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| July 2, 2014 | K141485 | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| March 31, 2014 | K140584 | ICEROD CX CRYOABLATION NEEDLE | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| August 28, 2012 | K121251 | ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| June 21, 2011 | K110946 | ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| April 27, 2006 | K060390 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| February 13, 2006 | K060144 | SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| May 6, 2005 | K051052 | SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| May 3, 2001 | K010991 | SEEDNET, MODELS FP6T5, FP5T5, FP5T3 | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| October 31, 2000 | K003065 | SEEDNET, MODEL EP6T5, EP5E5 | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Cryosurgical, Accessories
- All makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Updated October 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.