FDA Product Code MRD: Mammary Sizer
Leading manufacturers include Mentor Worldwide, LLC and Allergan.
FDA 510(k) Cleared Mammary Sizer Devices (Product Code MRD)
About Product Code MRD - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code MRD since 1983, with 13 receiving FDA clearance (average review time: 100 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for MRD submissions have been consistent, averaging 94 days recently vs 101 days historically.
MRD devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →