Product code QGC

Device name

Suprapubic Catheter Accessories

Medical specialty

Gastroenterology, Urology

Device class

1

Regulation number

876.5100

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset