FDA product code PGW: Ear, Nose, And Throat Stereotaxic Instrument
PGW is the FDA product code for ear, nose, and throat stereotaxic instrument. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 38 510(k) submissions under PGW, 8 in the last five years, from 12 different applicants. The average 510(k) review took 102 days (median 101); 176 days on average over the last three years. FDA has posted 17 recalls for PGW devices, 5 initiated in the last five years.
Definition
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Classification
| Field | Value |
|---|---|
| Device name | Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for PGW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 144 |
| 2018 | 2 | 103 |
| 2019 | 1 | 60 |
| 2020 | 8 | 88 |
| 2021 | 1 | 82 |
| 2022 | 2 | 96 |
| 2023 | 2 | 82 |
| 2025 | 1 | 266 |
| 2026 | 3 | 86 |
Compare with all 510(k) review times · Search every PGW clearance
Top PGW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fiagon GmbH | 11 | 2026-06-02 |
| Acclarent, Inc. | 8 | 2023-07-21 |
| Medtronic Navigation, Inc. | 6 | 2026-03-16 |
| Stryker Corporation | 2 | 2022-07-12 |
| Stryker Ent | 2 | 2020-02-21 |
7 more applicants have PGW clearances. See the full list in Caduvo.
Most recent PGW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262235 | Medtronic Xomed, Inc. | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM) | 2026-09-04 | 65 |
| K261540 | Fiagon GmbH | Cube 4D Navigation System, VirtuEye Pro | 2026-06-02 | 25 |
| K253395 | Medtronic Navigation, Inc. | Stealth AXiS ENT clinical application | 2026-03-16 | 167 |
| K243053 | Claronav | Navient Image Guided Navigation System (ENT) (955-NC-NC) | 2025-06-20 | 266 |
| K231862 | Acclarent, Inc. | TruDi® Navigation System V3 (FG-2000-00) | 2023-07-21 | 28 |
Recalls for PGW devices
17 product recalls in 8 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-10-03.
| Year | Recalls |
|---|---|
| 2017 | 9 |
| 2019 | 3 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code PGW?
PGW is the FDA product code for ear, nose, and throat stereotaxic instrument. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Ear, Nose and Throat panel.
What device class is PGW?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGW?
Across 38 cleared submissions the average was 102 days from receipt to decision (median 101).
Which companies have the most PGW clearances?
Fiagon GmbH (11); Acclarent, Inc. (8); Medtronic Navigation, Inc. (6); Stryker Corporation (2); Stryker Ent (2).
Have PGW devices been recalled?
Yes: 17 product recalls across 8 recall events; the most recent began 2025-10-03.
Next steps
- Run an FDA pathway report with predicate devices for product code PGW
- Run a recall and safety report across every PGW manufacturer
- Watch product code PGW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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