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U.S. Department of Health and Human Services

Product Classification

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Device mobile / tablet software application to control settings of surgical and endoscopic camera
Regulation Description Endoscope and accessories.
Definition Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.
Physical State Software only device without any physical part
Technical Method A software device that runs on a mobile or tablet device and wirelessly connects with compatible surgical or endoscopic camera control unit and patient information system.
Target Area Surgical sites within articular cavities, body cavities, hollow organs, canals and the thoracic cavity to obtain pictures or videos of these areas.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeQGY
Premarket Review 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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