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FDA 510(k)

EpiAccess System

K-Number: K170831 · 2017-05-09

ApplicantEpiep, Inc.
Decision Date2017-05-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EpiAccess System is a medical device manufactured by Epiep, Inc.. It received FDA 510(k) clearance on 2017-05-09 under approval number K170831. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EpiAccess System?

EpiAccess System is a medical device that received FDA 510(k) clearance on 2017-05-09. It is manufactured by Epiep, Inc.. The 510(k) number is K170831.

When was EpiAccess System approved by the FDA?

EpiAccess System received FDA 510(k) clearance on 2017-05-09, under approval number K170831.

What company makes EpiAccess System?

EpiAccess System is manufactured by Epiep, Inc..

What is the FDA product code for EpiAccess System?

The FDA product code for EpiAccess System is DYB.

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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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