EOXClass II
Esophagoscope (Flexible Or Rigid)
21 CFR 874.4710 / Ear, Nose, Throat
EOX is the FDA product code for Esophagoscope (Flexible Or Rigid), a class II device type, regulated under 21 CFR 874.4710. FDA's definition for this code reads: "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)". As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and 8 recalls.
Classification record
- Product code
- EOX
- Device name
- Esophagoscope (Flexible Or Rigid)
- FDA 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).
- Regulation
- 21 CFR 874.4710
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 30
- Ingested recalls
- 8
Clearances, product code EOX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1989 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 4 |
| 2003 | 1 |
| 2005 | 1 |
| 2007 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code EOX| Applicant | Clearances |
|---|---|
| Karl Storz Endoscopy-America, Inc. | 6 |
| Lucid Diagnostics, Inc. | 4 |
| Cogentix Medical, Inc. | 4 |
| Medtronic, Inc. | 3 |
| IntroMedic Co., Ltd. | 3 |
| Adn International, LLC | 1 |
| Biosearch Medical Products, Inc. | 1 |
| Capnostics, LLC | 1 |
| Cyted Limited | 1 |
| Karl Storz SE & Co. KG | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.