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U.S. Department of Health and Human Services

Product Classification

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Device endoscopic 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 Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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