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The NORTECH 40LPM ABDOMINAL INSUFFLATOR®, 72-00203-0 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.

The Abdominal CO, Gas Insufflator (catalog # 72-00203-0) incorporates front panel controls similar to our current Omniflator® model #7640, although it utilizes membrane switches. The Abdominal Insufflator has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO2 from a central supply or E-Cylinder tank.

This document is a 510(k) premarket notification for a laparoscopic insufflator. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices.

The document does not contain acceptance criteria for device performance or a study demonstrating that these criteria are met. This type of information is typically found in design verification and validation reports, which are part of the technical documentation submitted to the FDA but are not usually included in the public-facing 510(k) summary or cover letters.

Therefore, I cannot provide the requested information based solely on the provided text. The prompt asks for information that is not available in these specific parts of the 510(k) submission.

To answer your questions, I would need access to the actual performance and testing data, which are not present in the provided excerpt. The document only states that the device is substantially equivalent, implying that its performance is comparable to existing predicate devices, but it does not quantify this performance or detail specific tests.

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