Dornier Thulio
K-Number: K213252 · 2022-07-27
ApplicantDornier Medtech America, Inc.
Decision Date2022-07-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dornier Thulio is a medical device manufactured by Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2022-07-27 under approval number K213252. 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 Dornier Thulio?
Dornier Thulio is a medical device that received FDA 510(k) clearance on 2022-07-27. It is manufactured by Dornier Medtech America, Inc.. The 510(k) number is K213252.
When was Dornier Thulio approved by the FDA?
Dornier Thulio received FDA 510(k) clearance on 2022-07-27, under approval number K213252.
What company makes Dornier Thulio?
Dornier Thulio is manufactured by Dornier Medtech America, Inc..
What is the FDA product code for Dornier Thulio?
The FDA product code for Dornier Thulio 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.