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 (all years, FDA): 1 (all years; only the last 3 years are listed here)

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).

Official FDA classification page: OQL

Classification and pathway per current FDA publications. Data from openFDA (CC0).