TRIO Handpiece
K-Number: K183199 · 2019-05-02
ApplicantOmniguide, Inc.
Decision Date2019-05-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
TRIO Handpiece is a medical device manufactured by Omniguide, Inc.. It received FDA 510(k) clearance on 2019-05-02 under approval number K183199. 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 TRIO Handpiece?
TRIO Handpiece is a medical device that received FDA 510(k) clearance on 2019-05-02. It is manufactured by Omniguide, Inc.. The 510(k) number is K183199.
When was TRIO Handpiece approved by the FDA?
TRIO Handpiece received FDA 510(k) clearance on 2019-05-02, under approval number K183199.
What company makes TRIO Handpiece?
TRIO Handpiece is manufactured by Omniguide, Inc..
What is the FDA product code for TRIO Handpiece?
The FDA product code for TRIO Handpiece 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.