FDA product code QGD: Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

QGD is the FDA product code for implanted mechanical/hydraulic urinary continence device surgical accessories. It is a Class I device, regulated under 21 CFR 876.5290 and reviewed by the Gastroenterology and Urology panel. Devices under QGD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Definition

Implanted mechanical/hydraulic urinary continence device surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, tubing plug, incision closing tool, tubing passer, blunt needle, and hemostat shod tubing.

Classification

Recalls for QGD devices

openFDA lists no recalls for product code QGD.

Frequently asked questions

What is FDA product code QGD?

QGD is the FDA product code for implanted mechanical/hydraulic urinary continence device surgical accessories. It is a Class I device, regulated under 21 CFR 876.5290 and reviewed by the Gastroenterology and Urology panel.

What device class is QGD?

Class I, regulation 21 CFR 876.5290. Typical premarket route: 510(k) exempt.

Next steps

• Run an FDA pathway report with predicate devices for product code QGD
• Run a recall and safety report across every QGD manufacturer
• Watch product code QGD for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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