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510(k) K181153

ICEfx Cryoablation System by Galil Medical, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2018
Date Received
May 1, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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  • K152133 — IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit V (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)

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