Pre-Formed Penile Silicone Block— 510(k) K220760

Name: FDA 510(k) clearance K220760
Creator: U.S. Food and Drug Administration
Published: 2022-05-13

Substantially Equivalent

International Medical Devices, Inc.

FDA 510(k) clearance K220760 for Pre-Formed Penile Silicone Block, Substantially Equivalent on 2022-05-13. Applicant: International Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: International Medical Devices, Inc.
Product code: Code MIB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2022-03-15
Decision date: 2022-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, CA, US

Download summary PDF View on FDA.gov ↗

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K241150 — MISTI Silicone Implant2024-07-24
K223051 — Pre-Formed Silicone Block2023-02-03
K222748 — ShiNeo Silicone Implant2022-12-23
K200073 — AugMENTA Penile Implant2022-09-30
K193392 — BioSiCar Silicone Implant2020-07-20

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K181387 — Pre-Formed Penile Silicone Block2019-01-23
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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.