510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QGBClass I

Ureteral Stent Accessories

21 CFR 876.4630 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QGB is the FDA product code for Ureteral Stent Accessories, a class I device type, regulated under 21 CFR 876.4630. FDA's definition for this code reads: "Ureteral stent accessories aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QGB
Device name
Ureteral Stent Accessories
FDA definition
Ureteral stent accessories aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener.
Regulation
21 CFR 876.4630
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