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FDA 510(k)

TruDi Shaver Blade

K-Number: K221037 · 2022-07-20

ApplicantAcclarent, Inc.
Decision Date2022-07-20
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TruDi Shaver Blade is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2022-07-20 under 510(k) 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. The listed applicant is Acclarent, Inc.. The 510(k) number is K221037.

When did TruDi Shaver Blade receive FDA 510(k) clearance?

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

Who is the listed applicant for TruDi Shaver Blade?

The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TruDi Shaver Blade?

The FDA product code for TruDi Shaver Blade is PGW.

Other records listing Acclarent, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemK230742ACCLARENT AERA Eustachian Tube Dilation SystemK231862TruDi® Navigation System V3 (FG-2000-00)K201115Next Generation Balloon Dilation SystemK201174TruDi CuretteK193453TruDi Probe

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Related Devices (Code: PGW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbHK253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavK231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.K223734ENT EMBrainlab AGK221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker Corporation

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.

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