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U.S. Department of Health and Human Services

Product Classification
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Device system, surgical, computer controlled instrument, remanufactured
Regulation Description Endoscope and accessories.
Definition As intended with the originally cleared instrument.
Physical State A surgical instrument for a computer controlled system. The instrument has been remanufactured to extend its use life as compared to what was originally defined by the original equipment manufacturer.
Technical Method Instrument is attached and manipulated from a primary computer controlled system.
Target Area Where applicable in accordance to the indications for use.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeQSM
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
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		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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