FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
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
K Number: K152133
·
Decision Aug 28, 2015
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
23
Review Days
28
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Basic Information
- Device Name
- 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
- K Number
- K152133
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Galil Medical , Ltd.
- Date Received
- July 31, 2015
- Decision Date
- August 28, 2015
- Product Code
- GEH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Galil Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K181741 | IceSphere 1.5 CX Cryoablation Needle | Jul 30, 2018 | Substantially Equivalent |
| K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX L | Oct 11, 2016 | Substantially Equivalent |
| K141485 | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE | Jul 2, 2014 | Substantially Equivalent |
| K140584 | ICEROD CX CRYOABLATION NEEDLE | Mar 31, 2014 | Substantially Equivalent |
| K121251 | ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK | Aug 28, 2012 | Substantially Equivalent |
| K110946 | ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE | Jun 21, 2011 | Substantially Equivalent |
| K070482 | ISIS | Mar 20, 2007 | Substantially Equivalent |
| K060390 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA | Apr 27, 2006 | Substantially Equivalent |
| K060144 | SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS | Feb 13, 2006 | Substantially Equivalent |
| K052530 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA | Nov 18, 2005 | Substantially Equivalent |