DeviceClearance

Product code ORQ— General, Plastic Surgery

ACCUMESH DEPLOYMENT SYSTEM

Classification name
Mesh, Surgical, Deployer
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
6
First cleared
Most recent

FDA classification definition

“Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).”

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

Market context for product code ORQ

FDA has cleared 6 devices under product code ORQ between 2010 and 2025, filed by 3 applicant companies. 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.

Clearances per year

Top applicants under product code ORQ

Recent clearances under product code ORQ

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