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FDA 510(k)

Audion ET dilation system

K-Number: K220027 · 2022-04-12

ApplicantEntellus Medical, Inc.
Decision Date2022-04-12
Product CodePNZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Audion ET dilation system is the device name listed in this FDA 510(k) record. The listed applicant is Entellus Medical, Inc.. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K220027. The device is classified under product code PNZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Audion ET dilation system?

Audion ET dilation system is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K220027.

When did Audion ET dilation system receive FDA 510(k) clearance?

Audion ET dilation system received FDA 510(k) clearance on 2022-04-12, under 510(k) number K220027.

Who is the listed applicant for Audion ET dilation system?

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

What is the FDA product code for Audion ET dilation system?

The FDA product code for Audion ET dilation system is PNZ.

Other records listing Entellus Medical, 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.

K163509XprESS ENT Dilation SystemK163435Entellus Medical Reinforced Anesthesia Needle

Related Devices (Code: PNZ)

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 SystemAcclarent, Inc.K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbHK230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemFiagon GmbHK210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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