FDA Product Code QML: Anal Fistula Closure Device
An Anal Fistula Closure Device Is A Surgical Implant For Anal Fistula Repair And Is Intended For Closure Of The Anal Fistula. The Device May Be Manually Applied Or Delivered With A Delivery Device.
Leading manufacturers include Signum Surgical Limited.
1
Total
0
Cleared
150d
Avg days
2024
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Anal Fistula Closure Device Devices (Product Code QML)
1 devices
About Product Code QML - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QML since 2024, with 0 receiving FDA clearance (average review time: 150 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.