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U.S. Department of Health and Human Services

Product Classification

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Device endscopic magnetic retriever
Regulation Description Endoscope and accessories.
Definition To endoscopically retrieve magnetic foreign objects.
Physical State magnetic retriever
Technical Method place through endoscope to attract, capture, and remove magnet foreign bodies
Target Area magnetic foreign bodies in gi and gu tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFCC
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
Third Party Review
Accredited Persons

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