Ureteral Stent Accessories
The Ureteral Stent Accessories are manual devices that aid in the insertion of ureteral stents placed into the ureter to provide ureteral rigidity and allow the passage of urine, including stent positioners, wire guides, and pigtail straighteners. They are classified as FDA Class 1, with no premarket notification required, under regulation 876.4630 in the Gastroenterology and Urology specialty. The product code is QGB. These accessories are not themselves implants and are not life-sustaining.
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Basic Information
- Product Code
- QGB
- Device Class
- FDA class 1
- Regulation Number
- 876.4630
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.