EM ENT Navigated Suctions
K-Number: K153555 · 2016-04-07
ApplicantMedtronic Navigation, Inc.
Decision Date2016-04-07
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
EM ENT Navigated Suctions is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2016-04-07 under approval number K153555. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EM ENT Navigated Suctions?
EM ENT Navigated Suctions is a medical device that received FDA 510(k) clearance on 2016-04-07. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K153555.
When was EM ENT Navigated Suctions approved by the FDA?
EM ENT Navigated Suctions received FDA 510(k) clearance on 2016-04-07, under approval number K153555.
What company makes EM ENT Navigated Suctions?
EM ENT Navigated Suctions is manufactured by Medtronic Navigation, Inc..
What is the FDA product code for EM ENT Navigated Suctions?
The FDA product code for EM ENT Navigated Suctions is PGW.
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K162309StealthStation S8 System Platforms and StealthStation Cranial Software
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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.