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The Laparo CO2-Pneu automatic insufflator generates and maintains pneumoperitoneum under CO2 gas and can be used in diagnostic and operative laparoscopy.

The Laparo CO2-Pneu 2232 supplies CO2 gas from cylinders or central gas supplies to dilate the abdomen by the CO2 gas insufflation. The gas pressure and the flow rate are adjusted by the user and electronically controlled.

The provided 510(k) summary for the Richard Wolf Medical Instruments Corp. Laparo CO2-Pneu (K991906) indicates that no performance data or clinical tests were performed as part of this submission. Therefore, it is not possible to describe acceptance criteria and associated study details from this document.

The submission explicitly states:

• "5.0 Performance Data No performance data generated."
• "6.0 Clinical Tests No clinical tests performed."

The basis for market clearance was an assertion of substantial equivalence to existing 510(k) devices (K981334 and K955073), meaning the manufacturer demonstrated that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, those differences do not raise new questions of safety or effectiveness.

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