QGD

Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

Product code: QGD
Device name: Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
Device class: Class 1
21 CFR: 21 CFR 876.5290
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K) Exempt

FDA classification 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.

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

Official FDA classification page: QGD

Classification and pathway per current FDA publications. Data from openFDA (CC0).