ORQ

6 FDA 510(k) clearances · Product code

FDA profile

Official device name

Mesh, Surgical, Deployer

Device class

Class II (moderate risk)

Regulation

21 CFR 878.3300

Medical specialty

General, Plastic Surgery

FDA 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).

Adverse events (MAUDE)

2016: 10 · 2017: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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