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FDA 510(k)

SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)

K-Number: K051052 · 2005-05-06

ApplicantGalil Medical , Ltd.
Decision Date2005-05-06
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) 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 2005-05-06 under 510(k) number K051052. 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 SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)?

SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) is a medical device that received FDA 510(k) clearance on 2005-05-06. The listed applicant is Galil Medical , Ltd.. The 510(k) number is K051052.

When did SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) receive FDA 510(k) clearance?

SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) received FDA 510(k) clearance on 2005-05-06, under 510(k) number K051052.

Who is the listed applicant for SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)?

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 SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)?

The FDA product code for SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) 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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