FDA 510(k)

ORskin Blue

K-Number: K232858 · 2024-05-01

Decision Date2024-05-01

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORskin Blue is a medical device manufactured by Megabay S.A.. It received FDA 510(k) clearance on 2024-05-01 under approval number K232858. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORskin Blue?

ORskin Blue is a medical device that received FDA 510(k) clearance on 2024-05-01. It is manufactured by Megabay S.A.. The 510(k) number is K232858.

When was ORskin Blue approved by the FDA?

ORskin Blue received FDA 510(k) clearance on 2024-05-01, under approval number K232858.

What company makes ORskin Blue?

ORskin Blue is manufactured by Megabay S.A..

What is the FDA product code for ORskin Blue?

The FDA product code for ORskin Blue is GEX. This falls under the Gastroenterology category.

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Official Source

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