Ureteral Stent Accessories

QGB · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.4630

Classification

FDA Product Code: QGB
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 876.4630
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown