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FDA 510(k)

ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE

K-Number: K110946 · 2011-06-21

ApplicantGalil Medical , Ltd.
Decision Date2011-06-21
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Galil Medical , Ltd.. It received FDA 510(k) clearance on 2011-06-21 under 510(k) number K110946. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE?

ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE is a medical device that received FDA 510(k) clearance on 2011-06-21. The listed applicant is Galil Medical , Ltd.. The 510(k) number is K110946.

When did ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE receive FDA 510(k) clearance?

ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE received FDA 510(k) clearance on 2011-06-21, under 510(k) number K110946.

Who is the listed applicant for ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE?

The FDA 510(k) record lists Galil Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE?

The FDA product code for ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE is GEH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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