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FDA 510(k)

ORskin Blue

K-Number: K232858 · 2024-05-01

ApplicantMegabay S.A.
Decision Date2024-05-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORskin Blue is the device name listed in this FDA 510(k) record. The listed applicant is Megabay S.A.. It received FDA 510(k) clearance on 2024-05-01 under 510(k) 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. The listed applicant is Megabay S.A.. The 510(k) number is K232858.

When did ORskin Blue receive FDA 510(k) clearance?

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

Who is the listed applicant for ORskin Blue?

The FDA 510(k) record lists Megabay S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORskin Blue?

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

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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