FDA Product Code MIB: Elastomer, Silicone Block
Leading manufacturers include International Medical Devices, Inc., Keosan Trading Co. and Augmenta, LLC.
FDA 510(k) Cleared Elastomer, Silicone Block Devices (Product Code MIB)
About Product Code MIB - Regulatory Context
510(k) Submission Activity
45 total 510(k) submissions under product code MIB since 1992, with 45 receiving FDA clearance (average review time: 113 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under MIB have taken an average of 90 days to reach a decision - down from 114 days historically, suggesting improved FDA processing for this classification.
MIB devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →