QGA

Penile Implant Surgical Accessories

Product code

QGA

Device name

Penile Implant Surgical Accessories

Device class

Class 1

21 CFR

21 CFR 876.3500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

FDA classification definition

Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.

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