Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Acclarent NavWire Sinus Navigation Guidewire

K-Number: K161697 · 2016-10-24

ApplicantAcclarent, Inc.
Decision Date2016-10-24
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Acclarent NavWire Sinus Navigation Guidewire is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2016-10-24 under approval number K161697. 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 Acclarent NavWire Sinus Navigation Guidewire?

Acclarent NavWire Sinus Navigation Guidewire is a medical device that received FDA 510(k) clearance on 2016-10-24. It is manufactured by Acclarent, Inc.. The 510(k) number is K161697.

When was Acclarent NavWire Sinus Navigation Guidewire approved by the FDA?

Acclarent NavWire Sinus Navigation Guidewire received FDA 510(k) clearance on 2016-10-24, under approval number K161697.

What company makes Acclarent NavWire Sinus Navigation Guidewire?

Acclarent NavWire Sinus Navigation Guidewire is manufactured by Acclarent, Inc..

What is the FDA product code for Acclarent NavWire Sinus Navigation Guidewire?

The FDA product code for Acclarent NavWire Sinus Navigation Guidewire is PGW.

Other Devices by Acclarent, Inc.

K161698Relieva UltirraNav Sinus Balloon Catheter DEN150056Acclarent Aera Eustachian Tube Balloon Dilation System K153341Relieva Scout Multi-Sinus Dilation System K171687Relieva SpinPlus Nav Balloon Sinuplasty System K180948TruDi NAV Suction Instruments K173628Acclarent ENT Navigation System

View all 18 devices →

Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH 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. K160479PointerShell Universal, PointerShell LSFiagon 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.

↑