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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 a medical device manufactured by Entellus Medical, Inc.. It received FDA 510(k) clearance on 2017-04-05 under approval 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. It is manufactured by Entellus Medical, Inc.. The 510(k) number is K163509.

When was XprESS ENT Dilation System approved by the FDA?

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

What company makes XprESS ENT Dilation System?

XprESS ENT Dilation System is manufactured by Entellus Medical, Inc..

What is the FDA product code for XprESS ENT Dilation System?

The FDA product code for XprESS ENT Dilation System is PNZ.

Related Clinical Trials

NCT07211035 Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1) RECRUITING NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION NCT06380075 COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease RECRUITING NCT06748274 The Brain-Heart-Gut Connection COMPLETED

Other Devices by Entellus Medical, Inc.

K163435Entellus Medical Reinforced Anesthesia Needle K220027Audion ET dilation system

Related Devices (Code: PNZ)

DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemAcclarent, Inc. K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc. K220027Audion ET dilation systemEntellus Medical, Inc. K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc. K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH

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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