OQL

Mesh, Surgical, Deployment Balloon

Product code

OQL

Device name

Mesh, Surgical, Deployment Balloon

Device class

Class 2

21 CFR

21 CFR 878.3300

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

FDA classification definition

The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.

Definition text from the FDA device classification database (U.S. federal government work, public domain).