PGW · Class II · 21 CFR 882.4560

FDA Product Code PGW: Ear, Nose, And Throat Stereotaxic Instrument

Precise surgical navigation is essential in ENT surgery to avoid critical neurovascular structures. FDA product code PGW covers ear, nose, and throat stereotaxic instruments.

These navigation systems use preoperative CT or MRI data registered to the patient's anatomy to provide real-time spatial guidance during sinus surgery, skull base procedures, and cochlear implantation, reducing the risk of injury to the orbit, skull base, and cranial nerves.

PGW devices are Class II medical devices, regulated under 21 CFR 882.4560 and reviewed by the FDA Ear, Nose & Throat panel.

Leading manufacturers include Acclarent, Inc., Fiagon GmbH and Stryker Ent.

37
Total
37
Cleared
103d
Avg days
2014
Since
Declining activity - 3 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 153d recently vs 99d historically

FDA 510(k) Cleared Ear, Nose, And Throat Stereotaxic Instrument Devices (Product Code PGW)

37 devices
1–24 of 37
Cleared Jun 02, 2026
Cube 4D Navigation System, VirtuEye Pro
K261540
Fiagon GmbH
Ear, Nose, Throat · 25d
Cleared Mar 16, 2026
Stealth AXiS™ ENT clinical application
K253395
Medtronic Navigation, Inc.
Ear, Nose, Throat · 167d
Cleared Jun 20, 2025
Navient Image Guided Navigation System (ENT) (955-NC-NC)
K243053
Claronav
Ear, Nose, Throat · 266d
Cleared Jul 21, 2023
TruDi® Navigation System V3 (FG-2000-00)
K231862
Acclarent, Inc.
Ear, Nose, Throat · 28d
Cleared Apr 27, 2023
ENT EM
K223734
Brainlab AG
Ear, Nose, Throat · 135d
Cleared Jul 20, 2022
TruDi Shaver Blade
K221037
Acclarent, Inc.
Ear, Nose, Throat · 104d
Cleared Jul 12, 2022
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
K221098
Stryker Corporation
Ear, Nose, Throat · 89d
Cleared Jul 19, 2021
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
K211291
Fiagon GmbH
Ear, Nose, Throat · 82d
Cleared Oct 09, 2020
Instrument Clamps Electromagnetic
K202609
Stryker Corporation
Ear, Nose, Throat · 30d
Cleared Aug 12, 2020
TruDi Curette
K201174
Acclarent, Inc.
Ear, Nose, Throat · 103d
Cleared Jun 26, 2020
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
K200723
Medtronic Navigation, Inc.
Ear, Nose, Throat · 99d
Cleared Mar 23, 2020
TruDi Probe
K193453
Acclarent, Inc.
Ear, Nose, Throat · 101d
Cleared Mar 10, 2020
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
K200041
Fiagon GmbH
Ear, Nose, Throat · 62d
Cleared Feb 21, 2020
TGS Guidewire and updated Scopis Software
K193118
Stryker Ent
Ear, Nose, Throat · 101d
Cleared Feb 14, 2020
TGS Universal Headrest with Mounting Arm
K193502
Stryker Ent
Ear, Nose, Throat · 58d
Cleared Jan 30, 2020
TruDi Navigation System
K192397
Biosense Webster
Ear, Nose, Throat · 149d
Cleared May 03, 2019
TruDi NAV Wire
K190532
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared Jul 20, 2018
TruDi NAV Suction Instruments
K180948
Acclarent, Inc.
Ear, Nose, Throat · 100d
Cleared Mar 10, 2018
Acclarent ENT Navigation System
K173628
Acclarent, Inc.
Ear, Nose, Throat · 106d
Cleared Oct 21, 2016
KARL STORZ NAV1 Electromagnetic Navigation System
K161555
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 137d

About Product Code PGW - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code PGW since 2014, with 37 receiving FDA clearance (average review time: 103 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - PGW Product Code

Recent submissions under PGW have taken an average of 153 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.

PGW devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →