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510(k) K181741

IceSphere 1.5 CX Cryoablation Needle by Galil Medical , Ltd. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2018
Date Received
July 2, 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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  • 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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