Search Results

The disposable Cautery Tip Cleaner is a single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electro surgical instruments during the course of a surgical procedure.

Not Found

This is a premarket notification for an Electro-Cautery Tip Cleaner, a device designed to remove eschar build-up from electrosurgical instruments. The FDA has determined it is substantially equivalent to legally marketed predicate devices. Unfortunately, the provided document does not contain any information regarding specific acceptance criteria, performance data, or a study report for this device.

Therefore, I cannot provide the detailed information requested regarding the acceptance criteria and the study proving the device meets them. The document focuses on the regulatory approval process and not on the performance testing of the device itself.

Ask a specific question about this device

The Disposable Light Handle is a sterile product. It is intended to be used as an accessory to Surgical Lamps. This Disposable Handle provides a sterile interface between the operating room Surgical Lamp (non-sterile), and the Surgeon or Scrub Nurse (sterile)

Not Found

This document, an FDA 510(k) clearance letter for the "Disposable Light Handle and Adaptor," does not contain information about acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.

The letter is a regulatory document confirming that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA believes the new device is as safe and effective as a device already on the market, based on the information provided in the 510(k) submission.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on specific performance metrics or studies in the format you described.

Ask a specific question about this device