BioSiCar Silicone Implant— 510(k) K193392

Name: FDA 510(k) clearance K193392
Creator: U.S. Food and Drug Administration
Published: 2020-07-20

Substantially Equivalent

Metalware Technology Corp.

FDA 510(k) clearance K193392 for BioSiCar Silicone Implant, Substantially Equivalent on 2020-07-20. Applicant: Metalware Technology Corp.. Device class: 2.

Clearance details

Applicant: Metalware Technology Corp.
Product code: Code MIB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2019-12-06
Decision date: 2020-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code MIB

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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
K220760 — Pre-Formed Penile Silicone Block2022-05-13

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.