EOX — Esophagoscope (Flexible Or Rigid) Class II
FDA product code EOX covers "Esophagoscope (Flexible Or Rigid)", a Class II medical device regulated under 21 CFR 874.4710. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EOX
- Device Class
- Class II
- Regulation Number
- 874.4710
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233142 | Cyted Limited | EndoSign® Cell collection device (ES-CYT-102) | Jan 19, 2024 |
| K230339 | Lucid Diagnostics | EsoCheck Cell Collection Device | Feb 24, 2023 |
| K223072 | Pentax Of America | PENTAX Medical Video Esophagoscope EE17-J10 | Dec 2, 2022 |
| K222366 | Lucid Diagnostics | EsoCheck Cell Collection Device | Oct 26, 2022 |
| K203450 | Capnostics | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | May 4, 2021 |
| K210137 | Lucid Diagnostics | EsoCheck Cell Collection Device | Feb 18, 2021 |
| K192523 | Karl Storz Se And Co. Kg | CMOS Video Esophagoscope SSU | Jan 24, 2020 |
| K183262 | Lucid Diagnostics | EsoCheck CCD Cell Collection Device | Jun 21, 2019 |
| K182159 | Adn International | Strome-Blitzer Cytology Balloon | Jun 13, 2019 |
| K181292 | Cogentix Medical | PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor | Nov 15, 2018 |
| K181020 | Covidien | Cytosponge Cell Collection Device | Aug 16, 2018 |
| K152794 | Covidien | Cytosponge Cell Collection Device | Apr 12, 2016 |
| K142695 | Covidien | Cytosponge Cell Collection Device | Nov 26, 2014 |
| K131131 | Intromedic Co | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | Jun 21, 2013 |
| K120702 | Intromedic Co | E.G. SCAN II ESPHAGOSCOPE SYSTEM | Jun 20, 2012 |
| K111030 | Intromedic Co | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | Oct 21, 2011 |
| K072088 | Vision-Sciences | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOS | Aug 29, 2007 |
| K071903 | Vision-Sciences | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | Aug 2, 2007 |
| K051972 | Karl Storz Endoscopy-America | KARL STORZ TRANS-NASAL ESOPHAGOSCOPE | Aug 15, 2005 |
| K031786 | Vision-Sciences | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM | Aug 5, 2003 |