EOX — Esophagoscope (Flexible Or Rigid) Class II
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) | January 19, 2024 |
| K230339 | lucid diagnostics | EsoCheck Cell Collection Device | February 24, 2023 |
| K223072 | pentax of america | PENTAX Medical Video Esophagoscope EE17-J10 | December 2, 2022 |
| K222366 | lucid diagnostics | EsoCheck Cell Collection Device | October 26, 2022 |
| K203450 | capnostics | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | May 4, 2021 |
| K210137 | lucid diagnostics | EsoCheck Cell Collection Device | February 18, 2021 |
| K192523 | karl storz se and co. kg | CMOS Video Esophagoscope SSU | January 24, 2020 |
| K183262 | lucid diagnostics | EsoCheck CCD Cell Collection Device | June 21, 2019 |
| K182159 | adn international | Strome-Blitzer Cytology Balloon | June 13, 2019 |
| K181292 | cogentix medical | PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor | November 15, 2018 |
| K181020 | covidien | Cytosponge Cell Collection Device | August 16, 2018 |
| K152794 | covidien | Cytosponge Cell Collection Device | April 12, 2016 |
| K142695 | covidien | Cytosponge Cell Collection Device | November 26, 2014 |
| K131131 | intromedic co | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | June 21, 2013 |
| K120702 | intromedic co | E.G. SCAN II ESPHAGOSCOPE SYSTEM | June 20, 2012 |
| K111030 | intromedic co | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | October 21, 2011 |
| K072088 | vision-sciences | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOS | August 29, 2007 |
| K071903 | vision-sciences | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | August 2, 2007 |
| K051972 | karl storz endoscopy-america | KARL STORZ TRANS-NASAL ESOPHAGOSCOPE | August 15, 2005 |
| K031786 | vision-sciences | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM | August 5, 2003 |