Frova Intubating Introducer
K-Number: K171917 · 2018-04-23
ApplicantCook Incorporated
Decision Date2018-04-23
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Frova Intubating Introducer is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-04-23 under approval number K171917. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Frova Intubating Introducer?
Frova Intubating Introducer is a medical device that received FDA 510(k) clearance on 2018-04-23. It is manufactured by Cook Incorporated. The 510(k) number is K171917.
When was Frova Intubating Introducer approved by the FDA?
Frova Intubating Introducer received FDA 510(k) clearance on 2018-04-23, under approval number K171917.
What company makes Frova Intubating Introducer?
Frova Intubating Introducer is manufactured by Cook Incorporated.
What is the FDA product code for Frova Intubating Introducer?
The FDA product code for Frova Intubating Introducer is BTR.
Other Devices by Cook Incorporated
Related Devices (Code: BTR)
K152438ETView VivaSight-SL (TVT) systemEtview , Ltd.
K161813Frova Intubating IntroducerWilliam Cook Europe Aps
K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd.
K181880VivaSight-SL (TVT) systemEtview , Ltd.
K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc.
K170234Endotracheal tube; Reinforced Endotracheal tubeZhanjiang Star Enterprise Co., Ltd.
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.