510(k) DEN240007

BioHealx Anal Fistula Device by Signum Surgical Limited — Product Code QML

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: July 1, 2024
Date Received: February 2, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Anal Fistula Closure Device
Device Class: Class II
Regulation Number: 878.4835
Review Panel: SU
Submission Type

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.