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U.S. Department of Health and Human Services

Product Classification
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Device laparoscopic single port access device
Regulation Description Endoscope and accessories.
Definition A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Physical State multiple laparoscopic trocars and insufflation tube(s) bound by a flexible foam port.
Technical Method This device utilizes multiple laparoscopic trocars and insufflation tube(s) bound by a flexible foam port. The flexibility of the port enables laparoscopic instruments to be moved at different angles relative to each other.
Target Area abdominal
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeOTJ
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		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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