Product code QML

Device name

Anal Fistula Closure Device

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4835

Review panel

SU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset