everX Posterior
K-Number: K153127 · 2016-05-20
ApplicantGC America, Inc.
Decision Date2016-05-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
everX Posterior is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2016-05-20 under approval number K153127. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the everX Posterior?
everX Posterior is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by GC America, Inc.. The 510(k) number is K153127.
When was everX Posterior approved by the FDA?
everX Posterior received FDA 510(k) clearance on 2016-05-20, under approval number K153127.
What company makes everX Posterior?
everX Posterior is manufactured by GC America, Inc..
What is the FDA product code for everX Posterior?
The FDA product code for everX Posterior is EBF.
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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.