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Endoscopic Anti Fog Device is indicated for use during Endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endsoscopedevice, to prevent fogging of the endoscope lens.

Endoscopic Anti Fog Device (Mister Clear)

This document is a 510(k) clearance letter from the FDA for a device called "Endoscopic Anti Fog Device (Mister Clear)". It confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require a premarket approval application (PMA).

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The letter primarily focuses on the regulatory clearance process, referencing the device's classification, applicable regulations, and manufacturer responsibilities. It does not include performance data, clinical study results, or benchmarks for "anti-fog" effectiveness.

Therefore, I cannot provide the requested information based solely on this document. To answer your questions, I would need access to the actual 510(k) submission or any associated performance testing reports that Mectra Labs®, Inc. submitted to the FDA for the "Endoscopic Anti Fog Device (Mister Clear)".

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