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U.S. Department of Health and Human Services

Product Classification
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Device insufflator, endoscopic vessel harvesting
Definition To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Physical State An electronic software controlled gas insufflator which can accept CO2 gas from either a tank or central wall supply. The gas flow rate and pressure can be adjusted by the user.
Technical Method The insufflator delivers CO2 gas at a controlled flow rate and pressure to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Target Area Leg, saphenous vein or arm, radial artery
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeOSV
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.1730
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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