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U.S. Department of Health and Human Services

Product Classification

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Device mini endoscope, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To examine and perform procedures in body cavities of the gi and gu tract.
Physical State May include: handle, scope, fiberoptic attachment. Usually modular in nature. May be custom built
Technical Method Can be placed through working channel of a full sized endoscope. May also be used as a stand alone device
Target Area various body cavities in the GI and GU tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeODF
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
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible