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U.S. Department of Health and Human Services

Product Classification
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Device software controlled endoscope and instrument holder
Regulation Description Endoscope and accessories.
Definition To hold and position endoscopes and instruments.
Physical State Device includes hardware and software. Device includes sensors. The device is remotely controlled/ teleoperated by the user.
Technical Method Uses software to control the movement (i.e., location) of an endoscope or instrument.
Target Area Various body cavities related to general, gynecologic, and urologic surgical procedures.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeQZB
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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