QGB — Ureteral Stent Accessories Class I
FDA product code QGB covers "Ureteral Stent Accessories", a Class I medical device regulated under 21 CFR 876.4630. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- QGB
- Device Class
- Class I
- Regulation Number
- 876.4630
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.