FDA product code QML

Anal Fistula Closure Device

General, Plastic Surgery·Class 2·21 CFR 878.4835·Implantable
US regulatory classifications
US Product Code (FDA)
QML
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4835
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Anal Fistula Closure Device is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.