FDA Product Code MQR: Stent, Colonic, Metallic, Expandable
Leading manufacturers include Boston Scientific Corporation.
16
Total
16
Cleared
154d
Avg days
1996
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Stent, Colonic, Metallic, Expandable Devices (Product Code MQR)
16 devices
About Product Code MQR - Regulatory Context
510(k) Submission Activity
16 total 510(k) submissions under product code MQR since 1996, with 16 receiving FDA clearance (average review time: 154 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
MQR devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →