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U.S. Department of Health and Human Services

Product Classification

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Device endoscopic ultrasound system, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To provide ultrasonic visualization of body cavities that can be accessed by endoscope.
Physical State ultrasound system and system accessories, endoscope
Technical Method Uses ultrasound to visualize body cavities through endoscope
Target Area various body cavities, hollow organs, and canals in GI and GU tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeODG
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
Third Party Review Not Third Party Eligible
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