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FDA 510(k)

XprESS ENT Dilation System

K-Number: K163509 · 2017-04-05

ApplicantEntellus Medical, Inc.
Decision Date2017-04-05
Product CodePNZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

XprESS ENT 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 2017-04-05 under 510(k) number K163509. 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 XprESS ENT Dilation System?

XprESS ENT Dilation System is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K163509.

When did XprESS ENT Dilation System receive FDA 510(k) clearance?

XprESS ENT Dilation System received FDA 510(k) clearance on 2017-04-05, under 510(k) number K163509.

Who is the listed applicant for XprESS ENT 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 XprESS ENT Dilation System?

The FDA product code for XprESS ENT 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.

K220027Audion ET 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 GmbHK220027Audion ET dilation systemEntellus Medical, Inc.K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, 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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