FDA.report

510(k) K231862

Device
TruDi® Navigation System V3 (FG-2000-00)
Applicant
Acclarent, Inc.
510(k) number
K231862
Product code
PGW
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-21
Date received
2023-06-23
Regulation
882.4560
Classification name
Ear, Nose, And Throat Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Kamrie Sarnosky
Address
Suite 200, 31 Technology Dr. Irvine CA US 92618 92618

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code PGW

510(k)DeviceApplicantDecision date
K253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.2026-03-16
K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav2025-06-20
K223734ENT EMBrainlab AG2023-04-27
K221037TruDi Shaver BladeAcclarent, Inc.2022-07-20
K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker Corporation2022-07-12
K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH2021-07-19
K202609Instrument Clamps ElectromagneticStryker Corporation2020-10-09
K201174TruDi CuretteAcclarent, Inc.2020-08-12
K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)Medtronic Navigation, Inc.2020-06-26
K193453TruDi ProbeAcclarent, Inc.2020-03-23
K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH2020-03-10
K193118TGS Guidewire and updated Scopis SoftwareStryker Ent2020-02-21
K193502TGS Universal Headrest with Mounting ArmStryker Ent2020-02-14
K192397TruDi Navigation SystemBiosense Webster2020-01-30
K190532TruDi NAV WireAcclarent, Inc.2019-05-03