QGCClass I

Suprapubic Catheter Accessories

21 CFR 876.5100 / Gastroenterology, Urology

QGC is the FDA product code for Suprapubic Catheter Accessories, a class I device type, regulated under 21 CFR 876.5100. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QGC
Device name: Suprapubic Catheter Accessories
FDA 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.
Regulation: 21 CFR 876.5100
Device class: Class I
Review panel: Gastroenterology, Urology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QGC

FDA records hold no clearances under product code QGC.

Recent recalls

Product code QGC

FDA records show no recalls under product code QGC.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)