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FDA 510(k)

Superbium

K-Number: K153229 · 2016-04-12

ApplicantBios S.R.L.
Decision Date2016-04-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Superbium is the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2016-04-12 under 510(k) number K153229. 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 Superbium?

Superbium is a medical device that received FDA 510(k) clearance on 2016-04-12. The listed applicant is Bios S.R.L.. The 510(k) number is K153229.

When did Superbium receive FDA 510(k) clearance?

Superbium received FDA 510(k) clearance on 2016-04-12, under 510(k) number K153229.

Who is the listed applicant for Superbium?

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

What is the FDA product code for Superbium?

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

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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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