AugMENTA Penile Implant— 510(k) K200073

Name: FDA 510(k) clearance K200073
Creator: U.S. Food and Drug Administration
Published: 2022-09-30

Substantially Equivalent

Augmenta, LLC

FDA 510(k) clearance K200073 for AugMENTA Penile Implant, Substantially Equivalent on 2022-09-30. Applicant: Augmenta, LLC. Device class: 2.

Clearance details

Applicant: Augmenta, LLC
Product code: Code MIB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2020-01-14
Decision date: 2022-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MIB

view all

K241150 — MISTI Silicone Implant2024-07-24
K223051 — Pre-Formed Silicone Block2023-02-03
K222748 — ShiNeo Silicone Implant2022-12-23
K220760 — Pre-Formed Penile Silicone Block2022-05-13
K193392 — BioSiCar Silicone Implant2020-07-20

Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.