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The Prosurg's NeoScope (Cystourethroscope /Cystoureteroscope /Cystonephroscope/ Digital Video System (which includes the Digital video Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Urinary tract, and can be percutaneously to examine the interior of the kidney and using additional accessories can be used to perform various diagnostic and therapeutic procedures.

The Prosurg's Neoscope (Hysteroscopce) Digital Video System (which includes the Digital Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Gynecological tract, and can be percutaneously to examine the interior of the uterus and using additional accessories can be used to perform various diagnostic and therapeutic procedures.

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The provided text is a 510(k) premarket notification letter from the FDA to Prosurg, Inc. regarding their NeoScope™ Digital Video Endoscopic System. This document does not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment, sample sizes, or expert qualifications.

The letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing Prosurg, Inc. to market it. It outlines general regulations and compliance requirements but does not include any performance data or study specifics of the kind requested.

Therefore, I cannot provide the requested table and information based on the input text.

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Neoscope™ - Endoscopic Diagnostic and Treatment System is intended for cystoscopic, hysteroscopic laparoscopic and endoscopic treatment of urological, gynecological, gasteroenterological disorders and diseases of prostate, bladder, urethra, uterine cavity, stomach, GI, urinary tract and reproductive organs using biomaterials, laser & RF devices, tissue ablative and augmenting agents, microsurgical instrument and endoscopic accessories.

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This document is a 510(k) clearance letter from the FDA for a device called "NeoScope™ - Endoscopic Diagnostic & Treatment System". It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, not on presenting detailed performance data against specific acceptance criteria in the same way a de novo or PMA submission might.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device has been cleared for marketing based on its substantial equivalence for the stated indications for use, but it does not include the specifics of performance testing or acceptance criteria.

Ask a specific question about this device