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.
FDA 510(k) Cleared Anal Fistula Closure Device Devices (Product Code QML)
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 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.
QML devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →