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U.S. Department of Health and Human Services

Product Classification
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Device surgical smoke precipitator
Regulation Description Surgical smoke precipitator.
Definition The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.
Physical State The device consists of an ion delivery system and a power source.
Technical Method The device is introduced into the laparoscopic site and provides the source of the ions that charge the surgical smoke particles and facilitate precipitation of surgical smoke and other aerosolized particulates
Target Area The device is intended for laparoscopic surgery sites.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodePQM
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control Devices (DHT4C)
Submission Type 510(k)
Regulation Number 878.5050
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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