FDA product code EOX: Esophagoscope (Flexible Or Rigid)
EOX is the FDA product code for esophagoscope (flexible or rigid). It is a Class II device, regulated under 21 CFR 874.4710 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 30 510(k) submissions under EOX, 4 in the last five years, from 16 different applicants. The average 510(k) review took 109 days (median 69); 114 days on average over the last three years. FDA has posted 8 recalls for EOX devices, 3 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 | Esophagoscope (Flexible Or Rigid) |
| Device class | Class II |
| Regulation | 21 CFR 874.4710 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for EOX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 152 |
| 2019 | 2 | 259 |
| 2020 | 1 | 133 |
| 2021 | 2 | 96 |
| 2022 | 2 | 73 |
| 2023 | 1 | 17 |
| 2024 | 1 | 114 |
Compare with all 510(k) review times · Search every EOX clearance
Top EOX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 6 | 2005-08-15 |
| Lucid Diagnostics, Inc. | 4 | 2023-02-24 |
| Covidien, LLC | 3 | 2018-08-16 |
| Intromedic Co., Ltd. | 3 | 2013-06-21 |
| Vision-Sciences, Inc. | 3 | 2007-08-29 |
11 more applicants have EOX clearances. See the full list in Caduvo.
Most recent EOX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233142 | Cyted Limited | EndoSign® Cell collection device (ES-CYT-102) | 2024-01-19 | 114 |
| K230339 | Lucid Diagnostics, Inc. | EsoCheck Cell Collection Device | 2023-02-24 | 17 |
| K223072 | Pentax of America, Inc. | PENTAX Medical Video Esophagoscope EE17-J10 | 2022-12-02 | 63 |
| K222366 | Lucid Diagnostics, Inc. | EsoCheck Cell Collection Device | 2022-10-26 | 83 |
| K203450 | Capnostics, LLC | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | 2021-05-04 | 162 |
Recalls for EOX devices
8 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-04-24.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code EOX?
EOX is the FDA product code for esophagoscope (flexible or rigid). It is a Class II device, regulated under 21 CFR 874.4710 and reviewed by the Ear, Nose and Throat panel.
What device class is EOX?
Class II, regulation 21 CFR 874.4710. Typical premarket route: 510(k).
How long does a 510(k) take for product code EOX?
Across 30 cleared submissions the average was 109 days from receipt to decision (median 69).
Which companies have the most EOX clearances?
KARL STORZ Endoscopy-America, Inc. (6); Lucid Diagnostics, Inc. (4); Covidien, LLC (3); Intromedic Co., Ltd. (3); Vision-Sciences, Inc. (3).
Have EOX devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2024-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code EOX
- Run a recall and safety report across every EOX manufacturer
- Watch product code EOX 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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