ORQ

Mesh, Surgical, Deployer

Product code
ORQ
Device name
Mesh, Surgical, Deployer
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)
6

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).

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-07.

NumberDecision dateApplicantDevice nameSummary
K2503952025-04-07Conmed CorporationBioBrace ® RC Delivery SystemPDF

1 summaries are archived here for direct download.

Official FDA classification page: ORQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).