Search Results

The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "EndoSerter™". It states that the device is substantially equivalent to legally marketed predicate devices.

However, this letter does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documents for AI/ML devices.

The provided text only includes:

• Device Name: EndoSerter™
• Regulation Number: 21 CFR 886.4300
• Regulation Name: Intraocular lens guide (though the Indications for Use state it's for corneal endothelial allograft tissue insertion)
• Regulatory Class: Class I, reserved
• Product Code: OTZ
• Indications for Use: "The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures."

Therefore, I cannot provide the requested table or answer the specific questions (2-9) because the necessary information is not present in the given document.

This type of FDA letter is primarily for regulatory clearance based on substantial equivalence to a predicate device, rather than a detailed performance study report. For performance criteria and study details, one would typically look for a separate clinical study report, a verification and validation report, or perhaps a more detailed summary of safety and effectiveness from the manufacturer.

Ask a specific question about this device