FDA 510(k)

ShiNeo Silicone Implant

K-Number: K222748 · 2022-12-23

Decision Date2022-12-23

Product CodeMIB

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

ShiNeo Silicone Implant is a medical device manufactured by Shineo Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-23 under approval number K222748. 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 ShiNeo Silicone Implant?

ShiNeo Silicone Implant is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by Shineo Technology Co., Ltd.. The 510(k) number is K222748.

When was ShiNeo Silicone Implant approved by the FDA?

ShiNeo Silicone Implant received FDA 510(k) clearance on 2022-12-23, under approval number K222748.

What company makes ShiNeo Silicone Implant?

ShiNeo Silicone Implant is manufactured by Shineo Technology Co., Ltd..

What is the FDA product code for ShiNeo Silicone Implant?

The FDA product code for ShiNeo Silicone Implant is MIB.

Related Clinical Trials

NCT04985123 A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery COMPLETED

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026)

Related Devices (Code: MIB)

K162624Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. K171851SOFTXILBistool K181387Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. K193392BioSiCar Silicone ImplantMetalware Technology Corp. K200073AugMENTA Penile ImplantAugmenta, LLC K220760Pre-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.