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The Benesta ™ Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

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This document is a 510(k) clearance letter for the Benesta™ Hysteroscope. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

A 510(k) clearance signifies that the FDA has determined the device is substantially equivalent to a predicate device already on the market, meaning it has the same intended use and technological characteristics, or different technological characteristics but does not raise different questions of safety and effectiveness. The information provided in this clearance letter is primarily administrative, confirming the regulatory approval based on the comparison to a predicate device, rather than providing details of a direct clinical or standalone performance study with defined acceptance criteria for the new device.

Therefore, I cannot provide the requested information from the provided text. To answer your questions, you would typically need to review the 510(k) summary or detailed submission documents, which contain the specific performance data and comparisons to the predicate device.

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