QGC

Suprapubic Catheter Accessories

Product code: QGC
Device name: Suprapubic Catheter Accessories
Device class: Class 1
21 CFR: 21 CFR 876.5100
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K) Exempt

FDA classification definition

Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.

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

Official FDA classification page: QGC

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