DeviceClearance

Product code OQL— General, Plastic Surgery

MESH GPS - LARGE, SMALL, SM, SM SMALL

Classification name
Mesh, Surgical, Deployment Balloon
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OQL under 21 CFR 878.3300, via openFDA

Market context for product code OQL

FDA has cleared 1 device under product code OQL, all in 2010, 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 OQL

Recent clearances under product code OQL

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