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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.

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