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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Augmenta, LLC. It received FDA 510(k) clearance on 2022-09-30 under 510(k) 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. The listed applicant is Augmenta, LLC. The 510(k) number is K200073.

When did AugMENTA Penile Implant receive FDA 510(k) clearance?

AugMENTA Penile Implant received FDA 510(k) clearance on 2022-09-30, under 510(k) number K200073.

Who is the listed applicant for AugMENTA Penile Implant?

The FDA 510(k) record lists Augmenta, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AugMENTA Penile Implant?

The FDA product code for AugMENTA Penile Implant is MIB.

Related Devices (Code: MIB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241150MISTI Silicone ImplantKeosan Trading Co.K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.K220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.K193392BioSiCar Silicone ImplantMetalware Technology Corp.K181387Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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