FDA 510(k)

MISTI Silicone Implant

K-Number: K241150 · 2024-07-24

Decision Date2024-07-24

Product CodeMIB

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

MISTI Silicone Implant is a medical device manufactured by Keosan Trading Co.. It received FDA 510(k) clearance on 2024-07-24 under approval 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. It is manufactured by Keosan Trading Co.. The 510(k) number is K241150.

When was MISTI Silicone Implant approved by the FDA?

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

What company makes MISTI Silicone Implant?

MISTI Silicone Implant is manufactured by Keosan Trading Co..

What is the FDA product code for MISTI Silicone Implant?

The FDA product code for MISTI 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)

Other Devices by Keosan Trading Co.

K232593FITme Customized Silicone Implant

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. K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd. K200073AugMENTA Penile ImplantAugmenta, LLC

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.