FDA 510(k)

TruDi Probe

K-Number: K193453 · 2020-03-23

Decision Date2020-03-23

Product CodePGW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TruDi Probe is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2020-03-23 under approval number K193453. 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 Probe?

TruDi Probe is a medical device that received FDA 510(k) clearance on 2020-03-23. It is manufactured by Acclarent, Inc.. The 510(k) number is K193453.

When was TruDi Probe approved by the FDA?

TruDi Probe received FDA 510(k) clearance on 2020-03-23, under approval number K193453.

What company makes TruDi Probe?

TruDi Probe is manufactured by Acclarent, Inc..

What is the FDA product code for TruDi Probe?

The FDA product code for TruDi Probe is PGW.

Other Devices by Acclarent, Inc.

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Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. K161701CARTO ENT SystemBiosense Webster K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. K161940Guidewire 0.6 Single UseFiagon GmbH K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc.

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.