AugMENTA Penile Implant
K-Number: K200073 · 2022-09-30
ApplicantAugmenta, LLC
Decision Date2022-09-30
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
AugMENTA Penile Implant is a medical device manufactured by Augmenta, LLC. It received FDA 510(k) clearance on 2022-09-30 under approval number K200073. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AugMENTA Penile Implant?
AugMENTA Penile Implant is a medical device that received FDA 510(k) clearance on 2022-09-30. It is manufactured by Augmenta, LLC. The 510(k) number is K200073.
When was AugMENTA Penile Implant approved by the FDA?
AugMENTA Penile Implant received FDA 510(k) clearance on 2022-09-30, under approval number K200073.
What company makes AugMENTA Penile Implant?
AugMENTA Penile Implant is manufactured by Augmenta, LLC.
What is the FDA product code for AugMENTA Penile Implant?
The FDA product code for AugMENTA Penile Implant is MIB.
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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.