Product code QGD

Device name

Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

Medical specialty

Gastroenterology, Urology

Device class

1

Regulation number

876.5290

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset