EpiZact
K-Number: K233056 · 2023-11-02
ApplicantGuidestar Medical Devices
Decision Date2023-11-02
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
EpiZact is a medical device manufactured by Guidestar Medical Devices. It received FDA 510(k) clearance on 2023-11-02 under approval number K233056. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EpiZact?
EpiZact is a medical device that received FDA 510(k) clearance on 2023-11-02. It is manufactured by Guidestar Medical Devices. The 510(k) number is K233056.
When was EpiZact approved by the FDA?
EpiZact received FDA 510(k) clearance on 2023-11-02, under approval number K233056.
What company makes EpiZact?
EpiZact is manufactured by Guidestar Medical Devices.
What is the FDA product code for EpiZact?
The FDA product code for EpiZact is FMF.
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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.