FDA Product Code MJC: Catheter, Urological (antimicrobial) And Accessories
Leading manufacturers include Well Lead Medical (Hainan) Co., Ltd..
FDA 510(k) Cleared Catheter, Urological (antimicrobial) And Accessories Devices (Product Code MJC)
About Product Code MJC - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code MJC since 1994, with 10 receiving FDA clearance (average review time: 275 days).
Submission volume has increased in recent years - 1 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 MJC submissions have been consistent, averaging 254 days recently vs 277 days historically.
MJC devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →