Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4835](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4835) → QML — Anal Fistula Closure Device

# QML · Anal Fistula Closure Device

_General, Plastic Surgery · 21 CFR 878.4835 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QML

## Overview

- **Product Code:** QML
- **Device Name:** Anal Fistula Closure Device
- **Regulation:** [21 CFR 878.4835](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4835)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN240007](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QML/DEN240007.md) | BioHealx Anal Fistula Device | Signum Surgical Limited | Jul 1, 2024 | DENG |

## Top Applicants

- Signum Surgical Limited — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QML](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QML)

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