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U.S. Department of Health and Human Services

Product Classification
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Device endoscope channel accessory
Regulation Description Endoscope and accessories.
Definition To give the endoscope channel additional or improved functionality.
Physical State may include: biopsy cover, biopsy cap, external accessory channel, anti splatter device, locking device,
Technical Method attach to endoscope channel
Target Area endoscope channel
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeODC
Premarket Review Office of 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 Not Third Party Eligible
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