Gastroenterology, Urology— FDA advisory panel GU

11,279 FDA 510(k) clearances across 401 product codes since 1976.

By Andrew Weston — Installation Systems Engineer

A two-specialty panel joined by shared tooling: flexible and rigid endoscopes and their accessories, urological catheters, ureteral stents, lithotripsy systems, hemodialysis machines and dialyzers, bowel-management devices, and endoscopic therapeutic instruments (snares, clips, dilation balloons). Its high product-code count comes from the accessory ecosystems — every scope family drags a constellation of cleared accessories behind it.

Hemodialysis is the quiet heavyweight here: dialyzers, dialysate concentrates, and delivery systems all clear through this panel, and that equipment sits under sustained regulatory attention because of its direct-life-support role. On the GI side, watch the endoscopy accessory codes for the single-use trend — reusable-scope infection concerns have pushed a visible wave of disposable-instrument clearances in recent years.

Clearances per year

last 10 years

Top product codes in the Gastroenterology, Urology panel

all codes

Recent clearances in the Gastroenterology, Urology panel

all clearances

Data sourced from openFDA. This site is unofficial and independent of the FDA.