Anal Fistula Closure Device
The Anal Fistula Closure Device is a surgical implant intended for the repair and closure of anal fistulas. It may be manually applied or delivered with a delivery device, and is designed to promote healing of this challenging anorectal condition. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 878.4835 in the General and Plastic Surgery specialty. It carries product code QML and is flagged as an implant. It is not life-sustaining and is not GMP exempt.
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Basic Information
- Product Code
- QML
- Device Class
- FDA class 2
- Regulation Number
- 878.4835
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN240007 | BioHealx Anal Fistula Device | Jul 01, 2024 | Unknown | Signum Surgical Limited |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.