Not Cleared Direct

DEN240007 - BioHealx Anal Fistula Device (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240007 · Signum Surgical Limited · General & Plastic Surgery device
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Jul 2024
Decision
150d
Days
Class 2
Risk

DEN240007 is an FDA 510(k) submission (not cleared) for the BioHealx Anal Fistula Device. Classified as Anal Fistula Closure Device (product code QML), Class II - Special Controls.

Submitted by Signum Surgical Limited (Galway, IE). The FDA issued a Not Cleared (DENG) decision on July 1, 2024 after a review of 150 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4835 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General & Plastic Surgery review framework.

View all Signum Surgical Limited devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 114d · This submission: 150d
Pathway characteristics

Device Classification

Product Code QML Anal Fistula Closure Device
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.