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U.S. Department of Health and Human Services

Product Classification

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Device endoscopic injection needle, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition Inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Physical State needle and accessories to needle. does not include pneumoperitoneum needles
Technical Method instrument guided through endoscope to puncture desired tissue
Target Area gi and gu tissues
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFBK
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 Standard
Third Party Review
Accredited Persons

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