DeviceClearance

Product code QML— General, Plastic Surgery

BioHealx Anal Fistula Device

Classification name
Anal Fistula Closure Device
Device class
Class 2
Regulation
21 CFR 878.4835
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QML under 21 CFR 878.4835, via openFDA

Market context for product code QML

FDA has cleared 1 device under product code QML, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QML

Recent clearances under product code QML

Data sourced from openFDA. This site is unofficial and independent of the FDA.