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FDA 510(k)

KARL STORZ NAV1 Electromagnetic Navigation System

K-Number: K161555 · 2016-10-21

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2016-10-21
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KARL STORZ NAV1 Electromagnetic Navigation System is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2016-10-21 under approval number K161555. 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 KARL STORZ NAV1 Electromagnetic Navigation System?

KARL STORZ NAV1 Electromagnetic Navigation System is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K161555.

When was KARL STORZ NAV1 Electromagnetic Navigation System approved by the FDA?

KARL STORZ NAV1 Electromagnetic Navigation System received FDA 510(k) clearance on 2016-10-21, under approval number K161555.

What company makes KARL STORZ NAV1 Electromagnetic Navigation System?

KARL STORZ NAV1 Electromagnetic Navigation System is manufactured by Karl Storz Endoscopy America, Inc..

What is the FDA product code for KARL STORZ NAV1 Electromagnetic Navigation System?

The FDA product code for KARL STORZ NAV1 Electromagnetic Navigation System is PGW.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07221565 Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) ENROLLING_BY_INVITATION NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07095920 RESPARK - Brain Q for Chronic Stroke RECRUITING NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Karl Storz Endoscopy America, Inc.

K160044Image1 SPIES System K150969Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces K162992Karl Storz UROMAT E.A.S.I. K162880TIPCAM 1S 3D System K162410TIPCAM 1S 3D System K180146KARL STORZ ICG Imaging System

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Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. K161701CARTO ENT SystemBiosense Webster 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.

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