Decision Date2013-04-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PLASMATRODE SALINE SAFE TUR ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2013-04-17 under 510(k) number K122716. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PLASMATRODE SALINE SAFE TUR ELECTRODE?
PLASMATRODE SALINE SAFE TUR ELECTRODE is a medical device that received FDA 510(k) clearance on 2013-04-17. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K122716.
When did PLASMATRODE SALINE SAFE TUR ELECTRODE receive FDA 510(k) clearance?
PLASMATRODE SALINE SAFE TUR ELECTRODE received FDA 510(k) clearance on 2013-04-17, under 510(k) number K122716.
Who is the listed applicant for PLASMATRODE SALINE SAFE TUR ELECTRODE?
The FDA 510(k) record lists Cook Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PLASMATRODE SALINE SAFE TUR ELECTRODE?
The FDA product code for PLASMATRODE SALINE SAFE TUR ELECTRODE is GEI.
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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.