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 the device name listed in this FDA 510(k) record. The listed applicant is Shineo Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) 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. The listed applicant is Shineo Technology Co., Ltd.. The 510(k) number is K222748.

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

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

Who is the listed applicant for ShiNeo Silicone Implant?

The FDA 510(k) record lists Shineo Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ShiNeo Silicone Implant?

The FDA product code for ShiNeo 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.K200073AugMENTA Penile ImplantAugmenta, LLC K220760Pre-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.