QGC · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5100
Classification
FDA Product Code
QGC
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 876.5100
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.