FDA product code GWG: Endoscope, Neurological
GWG is the FDA product code for endoscope, neurological. It is a Class II device, regulated under 21 CFR 882.1480 and reviewed by the Neurology panel. FDA has cleared 93 510(k) submissions under GWG, 10 in the last five years, from 40 different applicants. The average 510(k) review took 157 days (median 118); 206 days on average over the last three years. FDA has posted 22 recalls for GWG devices, 4 initiated in the last five years.
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Neurological |
| Device class | Class II |
| Regulation | 21 CFR 882.1480 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for GWG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 126 |
| 2018 | 4 | 131 |
| 2019 | 3 | 156 |
| 2020 | 2 | 160 |
| 2021 | 3 | 171 |
| 2023 | 5 | 213 |
| 2024 | 1 | 324 |
| 2025 | 2 | 112 |
| 2026 | 2 | 183 |
Compare with all 510(k) review times · Search every GWG clearance
Top GWG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neuro Navigational Corp. | 15 | 1997-03-06 |
| KARL STORZ Endoscopy-America, Inc. | 8 | 2017-05-16 |
| Clarus Medical Systems, Inc. | 7 | 1996-12-24 |
| Aesculap, Inc. | 6 | 2014-11-14 |
| Penumbra, Inc. | 4 | 2019-08-30 |
35 more applicants have GWG clearances. See the full list in Caduvo.
Most recent GWG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253602 | Stryker Endoscopy | Precision S 4K Sinuscope | 2026-06-04 | 198 |
| K253679 | Stryker Instruments | Hydro Irrigation System | 2026-05-08 | 168 |
| K243429 | Hjy Smart Medical Device Co., Ltd. | HJY VisualNext 3D Endoscopic Vision System | 2025-05-21 | 197 |
| K250752 | Integra LifeSciences Corporation | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | 2025-04-09 | 28 |
| K233391 | VPIX Medical, Inc. | cCeLL - In vivo | 2024-08-21 | 324 |
Recalls for GWG devices
22 product recalls in 15 recall events; 4 initiated in the last five years and 7 still open. Most recent: 2026-01-15.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 4 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code GWG?
GWG is the FDA product code for endoscope, neurological. It is a Class II device, regulated under 21 CFR 882.1480 and reviewed by the Neurology panel.
What device class is GWG?
Class II, regulation 21 CFR 882.1480. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWG?
Across 93 cleared submissions the average was 157 days from receipt to decision (median 118).
Which companies have the most GWG clearances?
Neuro Navigational Corp. (15); KARL STORZ Endoscopy-America, Inc. (8); Clarus Medical Systems, Inc. (7); Aesculap, Inc. (6); Penumbra, Inc. (4).
Have GWG devices been recalled?
Yes: 22 product recalls across 15 recall events; the most recent began 2026-01-15.
Next steps
- Run an FDA pathway report with predicate devices for product code GWG
- Run a recall and safety report across every GWG manufacturer
- Watch product code GWG 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times