TruDi NAV Suction Instruments
K-Number: K180948 · 2018-07-20
ApplicantAcclarent, Inc.
Decision Date2018-07-20
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TruDi NAV Suction Instruments is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2018-07-20 under approval number K180948. 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 TruDi NAV Suction Instruments?
TruDi NAV Suction Instruments is a medical device that received FDA 510(k) clearance on 2018-07-20. It is manufactured by Acclarent, Inc.. The 510(k) number is K180948.
When was TruDi NAV Suction Instruments approved by the FDA?
TruDi NAV Suction Instruments received FDA 510(k) clearance on 2018-07-20, under approval number K180948.
What company makes TruDi NAV Suction Instruments?
TruDi NAV Suction Instruments is manufactured by Acclarent, Inc..
What is the FDA product code for TruDi NAV Suction Instruments?
The FDA product code for TruDi NAV Suction Instruments is PGW.
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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.