Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BioSiCar Silicone Implant

K-Number: K193392 · 2020-07-20

ApplicantMetalware Technology Corp.
Decision Date2020-07-20
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BioSiCar Silicone Implant is the device name listed in this FDA 510(k) record. The listed applicant is Metalware Technology Corp.. It received FDA 510(k) clearance on 2020-07-20 under 510(k) number K193392. 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 BioSiCar Silicone Implant?

BioSiCar Silicone Implant is a medical device that received FDA 510(k) clearance on 2020-07-20. The listed applicant is Metalware Technology Corp.. The 510(k) number is K193392.

When did BioSiCar Silicone Implant receive FDA 510(k) clearance?

BioSiCar Silicone Implant received FDA 510(k) clearance on 2020-07-20, under 510(k) number K193392.

Who is the listed applicant for BioSiCar Silicone Implant?

The FDA 510(k) record lists Metalware Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioSiCar Silicone Implant?

The FDA product code for BioSiCar Silicone 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.K200073AugMENTA Penile ImplantAugmenta, LLCK220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.K181387Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.

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.

↑