FDA 510(k)

TruDi Shaver Blade

K-Number: K221037 · 2022-07-20

Decision Date2022-07-20

Product CodePGW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TruDi Shaver Blade is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2022-07-20 under approval number K221037. 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 Shaver Blade?

TruDi Shaver Blade is a medical device that received FDA 510(k) clearance on 2022-07-20. It is manufactured by Acclarent, Inc.. The 510(k) number is K221037.

When was TruDi Shaver Blade approved by the FDA?

TruDi Shaver Blade received FDA 510(k) clearance on 2022-07-20, under approval number K221037.

What company makes TruDi Shaver Blade?

TruDi Shaver Blade is manufactured by Acclarent, Inc..

What is the FDA product code for TruDi Shaver Blade?

The FDA product code for TruDi Shaver Blade is PGW.

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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.