TruDi Curette
K-Number: K201174 · 2020-08-12
ApplicantAcclarent, Inc.
Decision Date2020-08-12
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TruDi Curette is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2020-08-12 under approval number K201174. 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 Curette?
TruDi Curette is a medical device that received FDA 510(k) clearance on 2020-08-12. It is manufactured by Acclarent, Inc.. The 510(k) number is K201174.
When was TruDi Curette approved by the FDA?
TruDi Curette received FDA 510(k) clearance on 2020-08-12, under approval number K201174.
What company makes TruDi Curette?
TruDi Curette is manufactured by Acclarent, Inc..
What is the FDA product code for TruDi Curette?
The FDA product code for TruDi Curette is PGW.
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K180948TruDi NAV Suction Instruments
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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.