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reprocessed phaco tips
Sterilmed
Summary: Reprocessed phaco tips are used in cataract surgery to emulsify the eye's lens. Ophthalmologists use these devices in surgical settings to improve patient outcomes.
FDA Clearance Information
Pathway
510K
Number
K012579 ↗
Decision Date
November 8, 2001
Product Code
NKX
Device Class
Class 2
Evidence
0 studies
The reprocessed phaco tips by Sterilmed were cleared through the FDA 510(k) pathway on November 8, 2001. They are classified as Class 2 devices under product code NKX.
What It Is
Reprocessed phaco tips are surgical instruments used in phacoemulsification, a common procedure for cataract removal. These tips are designed to emulsify and aspirate the eye's lens using ultrasonic vibrations. Reprocessing involves cleaning, sterilizing, and testing the tips to ensure they meet safety and performance standards equivalent to new devices.
Clinical Applications
Reprocessed phaco tips are primarily used in ophthalmology, particularly in cataract surgeries. They are utilized in both outpatient and hospital settings, where cataract extraction is performed. The device is suitable for adult and elderly patients who require lens removal due to cataracts, which is a common age-related condition.
Indications for Use
The FDA indications for reprocessed phaco tips are for use in cataract surgeries to emulsify and aspirate the lens. This device is intended for patients with cataracts, a condition characterized by clouding of the eye's lens, leading to impaired vision.
Practical Considerations
Reprocessed phaco tips are available in various sizes to accommodate different surgical needs and patient anatomies. They are compatible with standard phacoemulsification machines. Clinicians should ensure proper handling and attachment to prevent damage and maintain sterility.
Frequently Asked Questions
What is reprocessed phaco tips used for?
Reprocessed phaco tips are used in cataract surgery to emulsify and aspirate the eye's lens.
What specialties typically use this device?
Ophthalmologists typically use reprocessed phaco tips in cataract surgeries.
What are the FDA-cleared indications?
The device is indicated for use in cataract surgeries to emulsify and aspirate the lens in patients with cataracts.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.