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 a medical device manufactured by Bios S.R.L.. It received FDA 510(k) clearance on 2016-04-12 under approval 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. It is manufactured by Bios S.R.L.. The 510(k) number is K153229.
When was Superbium approved by the FDA?
Superbium received FDA 510(k) clearance on 2016-04-12, under approval number K153229.
What company makes Superbium?
Superbium is manufactured by Bios S.R.L..
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.