FDA product code EWY: Mediastinoscope, Surgical
EWY is the FDA product code for mediastinoscope, surgical. It is a Class II device, regulated under 21 CFR 874.4720 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 11 510(k) submissions under EWY, 2 in the last five years, from 7 different applicants. The average 510(k) review took 128 days (median 123); 59 days on average over the last three 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 | Mediastinoscope, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 874.4720 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for EWY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 123 |
| 2021 | 1 | 273 |
| 2022 | 1 | 267 |
| 2026 | 1 | 59 |
Compare with all 510(k) review times · Search every EWY clearance
Top EWY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Corp. | 3 | 1993-03-16 |
| Karl Storz Endoscopy America, Inc. | 2 | 2022-06-23 |
| Aegis Surgical, Ltd. | 2 | 2016-02-26 |
| Karl Storz SE & CO. KG | 1 | 2026-03-02 |
| Boston-Biomedical Associates | 1 | 2017-07-14 |
2 more applicants have EWY clearances. See the full list in Caduvo.
Most recent EWY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260003 | Karl Storz SE & CO. KG | KARL STORZ Mediastinoscopes and Instruments | 2026-03-02 | 59 |
| K213194 | Karl Storz Endoscopy America, Inc. | HD Mediastinoscope | 2022-06-23 | 267 |
| K202272 | Karl Storz Endoscopy America, Inc. | HD Mediastinoscope | 2021-05-11 | 273 |
| K170757 | Boston-Biomedical Associates | Aegis Transit System | 2017-07-14 | 123 |
| K160171 | Aegis Surgical, Ltd. | Illuminated Mediastinal Access Port | 2016-02-26 | 30 |
Recalls for EWY devices
openFDA lists no recalls for product code EWY.
Frequently asked questions
What is FDA product code EWY?
EWY is the FDA product code for mediastinoscope, surgical. It is a Class II device, regulated under 21 CFR 874.4720 and reviewed by the Ear, Nose and Throat panel.
What device class is EWY?
Class II, regulation 21 CFR 874.4720. Typical premarket route: 510(k).
How long does a 510(k) take for product code EWY?
Across 11 cleared submissions the average was 128 days from receipt to decision (median 123).
Which companies have the most EWY clearances?
Olympus Corp. (3); Karl Storz Endoscopy America, Inc. (2); Aegis Surgical, Ltd. (2); Karl Storz SE & CO. KG (1); Boston-Biomedical Associates (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EWY
- Run a recall and safety report across every EWY manufacturer
- Watch product code EWY 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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