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FDA 510(k)

MISTI Silicone Implant

K-Number: K241150 · 2024-07-24

ApplicantKeosan Trading Co.
Decision Date2024-07-24
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MISTI Silicone Implant is the device name listed in this FDA 510(k) record. The listed applicant is Keosan Trading Co.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K241150. 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 MISTI Silicone Implant?

MISTI Silicone Implant is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Keosan Trading Co.. The 510(k) number is K241150.

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

MISTI Silicone Implant received FDA 510(k) clearance on 2024-07-24, under 510(k) number K241150.

Who is the listed applicant for MISTI Silicone Implant?

The FDA 510(k) record lists Keosan Trading Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MISTI Silicone Implant?

The FDA product code for MISTI Silicone Implant is MIB.

Other records listing Keosan Trading Co. 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.

K232593FITme Customized Silicone Implant

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.

K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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