FDA 510(k) Gastroenterology & Urology Devices

FDA 510(k) Gastroenterology & Urology Devices - Regulatory Overview

FDA 510(k) gastroenterology and urology devices cover diagnostic and interventional equipment for the GI tract and urinary system. The FDA review panel code is GU.

Common device types:

• GI endoscopes - gastroscopes, colonoscopes, duodenoscopes and capsule endoscopy
• Biliary and pancreatic stents - metal and plastic biliary drainage devices
• Urological devices - ureteral stents, catheters, stone retrieval baskets
• Ablation systems - RFA and cryoablation for GI lesions
• Anorectal devices - manometry systems, hemorrhoid treatment