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U.S. Department of Health and Human Services

Product Classification

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Device sigmoidoscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition to examine and perform procedures within the sigmoid (descending) colon
Physical State endoscope, accessories associated with sigmoidoscope
Technical Method instrument guided through rectum into the large intestine
Target Area sigmoid (descending) colon
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFAM
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
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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