Search Results

Ask a specific question about this device

Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.

Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.

This document is a 510(k) premarket notification decision letter from the FDA for the "Electro-Lube" device. It does not contain any information about acceptance criteria, device performance, or any studies conducted on the device.

The letter is a regulatory compliance document, stating that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It lists the device's indications for use and general regulatory requirements.

Therefore, I cannot provide the requested information based on the given input, as it is not present in the document.

Ask a specific question about this device

Pneumoperitoneum Insufflation Needle is intended for use during Endoscopic procedures, to establish a pneumoperitoneum prior to abdominal endoscopy.

Not Found

This document (a 510(k) clearance letter) does not contain information on acceptance criteria or a study proving that the device meets acceptance criteria. It only indicates that the device (Pneumoperitoneum Insufflation Needle) is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

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)".

Ask a specific question about this device

Ask a specific question about this device