BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)

• K Number: K023758
• Device Name: BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
• Manufacturer: FCI OPHTHALMICS, INC.
• Date Cleared: 2003-09-17 ( 313 days)
• Product Code: OKS
• Regulation Number: N/A
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The Transnasal Lacrimal Stent is indicated in treatments of epiphora treated by dacryocystorhinostomy. Dacryocystorhinostomy (DCR) is the common surgical procedure used to correct nasolacrimal duct obstruction.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) substantial equivalence letter for the Becker Transnasal Lacrimal Stent. It does not contain information about acceptance criteria or specific study details proving device performance. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence rather than detailed performance study results.

Regulation Number and Section

N/A