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 a medical device manufactured by International Medical Devices, Inc.. It received FDA 510(k) clearance on 2023-02-03 under approval 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. It is manufactured by International Medical Devices, Inc.. The 510(k) number is K223051.
When was Pre-Formed Silicone Block approved by the FDA?
Pre-Formed Silicone Block received FDA 510(k) clearance on 2023-02-03, under approval number K223051.
What company makes Pre-Formed Silicone Block?
Pre-Formed Silicone Block is manufactured by International Medical Devices, Inc..
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
Other Devices by International Medical Devices, Inc.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.