Home / 510(k) Clearances / K203032

510(k) 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 by Galil Medical, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2020
Date Received
October 5, 2020
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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  • K173037 — Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual (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 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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