510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240007Unknown

BioHealx Anal Fistula Device

Signum Surgical Limited, Galway, IE / Direct, Unknown
FDA source (opens on fda.gov)

DEN240007 is the FDA 510(k) clearance record for BioHealx Anal Fistula Device, a class II device, cleared for Signum Surgical Limited on under FDA product code QML (Anal Fistula Closure Device). FDA's definition for product code QML reads: "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". FDA records list one 510(k) clearance for Signum Surgical Limited. As of , FDA records show no recalls naming DEN240007.

Clearance record

Decision date
Received
(150 days to decision)
Product code
QML Anal Fistula Closure Device
Regulation
21 CFR 878.4835
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Signum Surgical Limited Galway Harbour Enterprise Par, New Docks, The Docks, Galway, IE
Third party review
No

Clearances, product code QML

Trailing 12 months

FDA records hold no clearances under product code QML in the trailing twelve months.

FDA records show no clearances under product code QML in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QML, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260