Galil Medical, Inc.
FDA Regulatory Profile
Galil Medical, Inc. appears in FDA public data with 2 recalls, 31 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0404-2020, Class II) was initiated on October 25, 2019. Its most recent 510(k) clearance was granted on November 2, 2020.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 31
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0404-2020 | Class II | Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system inten | October 25, 2019 |
| Z-2261-2012 | Class II | Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cr | July 20, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K203032 | IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90 | November 2, 2020 |
| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2 | July 9, 2020 |
| K181741 | IceSphere 1.5 CX Cryoablation Needle | July 30, 2018 |
| K181153 | ICEfx Cryoablation System | May 15, 2018 |
| K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Conn | November 21, 2017 |
| K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX L | October 11, 2016 |
| K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, Ic | August 28, 2015 |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | March 5, 2015 |
| K141485 | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE | July 2, 2014 |
| K140584 | ICEROD CX CRYOABLATION NEEDLE | March 31, 2014 |
| K123865 | VISUAL-ICE CRYOABLATION SYSTEM | February 6, 2013 |
| K121251 | ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK | August 28, 2012 |
| K113860 | VISUAL-ICE CRYOABLATION SYSTEM | March 12, 2012 |
| K111859 | ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK | October 7, 2011 |
| K110946 | ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE | June 21, 2011 |
| K070482 | ISIS | March 20, 2007 |
| K060390 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA | April 27, 2006 |
| K060144 | SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS | February 13, 2006 |
| K052530 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA | November 18, 2005 |
| K051052 | SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) | May 6, 2005 |