DEN240007 is an FDA 510(k) submission for the BioHealx Anal Fistula Device. This device is classified as a Anal Fistula Closure Device (Class II - Special Controls, product code QML).
Submitted by Signum Surgical Limited (Galway, IE). The FDA issued a Not Cleared (DENG) decision on July 1, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4835. 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..
| 510(k) Number | DEN240007 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 02, 2024 |
| Decision Date | July 01, 2024 |
| Days to Decision | 150 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | QML - Anal Fistula Closure Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4835 |
| Definition | 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. |