QGD · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5290
Classification
FDA Product Code
QGD
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 876.5290
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.