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FDA 510(k)

Pre-Formed Silicone Block

K-Number: K223051 · 2023-02-03

ApplicantInternational Medical Devices, Inc.
Decision Date2023-02-03
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Pre-Formed Silicone Block is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Devices, Inc.. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K223051. 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 Pre-Formed Silicone Block?

Pre-Formed Silicone Block is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is International Medical Devices, Inc.. The 510(k) number is K223051.

When did Pre-Formed Silicone Block receive FDA 510(k) clearance?

Pre-Formed Silicone Block received FDA 510(k) clearance on 2023-02-03, under 510(k) number K223051.

Who is the listed applicant for Pre-Formed Silicone Block?

The FDA 510(k) record lists International Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pre-Formed Silicone Block?

The FDA product code for Pre-Formed Silicone Block is MIB.

Related Clinical Trials

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.

NCT04985123A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant SurgeryCOMPLETED

Other records listing International Medical Devices, Inc. as applicant

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.

K220760Pre-Formed Penile Silicone BlockK181387Pre-Formed Penile Silicone BlockK162624Pre-Formed Penile Silicone Block

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.K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.K200073AugMENTA Penile ImplantAugmenta, LLCK220760Pre-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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