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FDA 510(k)

Phacoemulsification Needle (Tip) and Irrigation Sleeve

K-Number: K192418 · 2020-05-27

ApplicantRaico, LLC
Decision Date2020-05-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Phacoemulsification Needle (Tip) and Irrigation Sleeve is a medical device manufactured by Raico, LLC. It received FDA 510(k) clearance on 2020-05-27 under approval number K192418. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phacoemulsification Needle (Tip) and Irrigation Sleeve?

Phacoemulsification Needle (Tip) and Irrigation Sleeve is a medical device that received FDA 510(k) clearance on 2020-05-27. It is manufactured by Raico, LLC. The 510(k) number is K192418.

When was Phacoemulsification Needle (Tip) and Irrigation Sleeve approved by the FDA?

Phacoemulsification Needle (Tip) and Irrigation Sleeve received FDA 510(k) clearance on 2020-05-27, under approval number K192418.

What company makes Phacoemulsification Needle (Tip) and Irrigation Sleeve?

Phacoemulsification Needle (Tip) and Irrigation Sleeve is manufactured by Raico, LLC.

What is the FDA product code for Phacoemulsification Needle (Tip) and Irrigation Sleeve?

The FDA product code for Phacoemulsification Needle (Tip) and Irrigation Sleeve is HQC.

Related Clinical Trials

NCT05729477 A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device TERMINATED

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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