Stardust Med
K-Number: K200736 · 2020-06-26
ApplicantI.T.S. Group S.R.L.
Decision Date2020-06-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Stardust Med is a medical device manufactured by I.T.S. Group S.R.L.. It received FDA 510(k) clearance on 2020-06-26 under approval number K200736. 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 Stardust Med?
Stardust Med is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by I.T.S. Group S.R.L.. The 510(k) number is K200736.
When was Stardust Med approved by the FDA?
Stardust Med received FDA 510(k) clearance on 2020-06-26, under approval number K200736.
What company makes Stardust Med?
Stardust Med is manufactured by I.T.S. Group S.R.L..
What is the FDA product code for Stardust Med?
The FDA product code for Stardust Med 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.