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FDA 510(k)

iPrime Viscodelivery System

K-Number: K212797 · 2022-01-06

ApplicantGlaukos
Decision Date2022-01-06
Product CodeMRH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

iPrime Viscodelivery System is a medical device manufactured by Glaukos. It received FDA 510(k) clearance on 2022-01-06 under approval number K212797. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iPrime Viscodelivery System?

iPrime Viscodelivery System is a medical device that received FDA 510(k) clearance on 2022-01-06. It is manufactured by Glaukos. The 510(k) number is K212797.

When was iPrime Viscodelivery System approved by the FDA?

iPrime Viscodelivery System received FDA 510(k) clearance on 2022-01-06, under approval number K212797.

What company makes iPrime Viscodelivery System?

iPrime Viscodelivery System is manufactured by Glaukos.

What is the FDA product code for iPrime Viscodelivery System?

The FDA product code for iPrime Viscodelivery System is MRH.

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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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