Product code EOX
- Device name
- Esophagoscope (Flexible Or Rigid)
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.4710
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | 2024-01-19 |
| K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2023-02-24 |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | 2022-12-02 |
| K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2022-10-26 |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | Capnostics, LLC | 2021-05-04 |
| K210137 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2021-02-18 |
| K192523 | CMOS Video Esophagoscope SSU | Karl Storz SE & CO. KG | 2020-01-24 |
| K183262 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics, Inc. | 2019-06-21 |
| K182159 | Strome-Blitzer Cytology Balloon | Adn International, LLC | 2019-06-13 |
| K181292 | PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor | Cogentix Medical, Inc. | 2018-11-15 |
| K181020 | Cytosponge Cell Collection Device | Covidien, LLC | 2018-08-16 |
| K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016-04-12 |
| K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014-11-26 |
| K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2013-06-21 |
| K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2012-06-20 |
| K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2011-10-21 |
| K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS | Vision-Sciences, Inc. | 2007-08-29 |
| K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | Vision-Sciences, Inc. | 2007-08-02 |
| K051972 | KARL STORZ TRANS-NASAL ESOPHAGOSCOPE | KARL STORZ Endoscopy-America, Inc. | 2005-08-15 |
| K031786 | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 2003-08-05 |
| K953849 | PRISM ELECTROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1995-09-06 |
| K951395 | KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES | KARL STORZ Endoscopy-America, Inc. | 1995-05-09 |
| K951424 | M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM | M.E.R. Surgical Co. | 1995-05-09 |
| K946331 | KARL STORZ BOUGIES, SOUNDS, DILATORS | KARL STORZ Endoscopy-America, Inc. | 1995-03-02 |
| K945237 | KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE | KARL STORZ Endoscopy-America, Inc. | 1994-12-21 |
| K943667 | ESOPHAGOSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1994-08-18 |
| K934193 | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST | Biosearch Medical Products, Inc. | 1993-11-19 |
| K911588 | BRANDT ESOPHAGEAL CYTOLOGY BALLOON | Wilson-Cook Medical, Inc. | 1992-11-18 |
| K892259 | JESBERG ESOPHAGOSCOPE | Zinnanti Surgical Instruments, Inc. | 1989-06-16 |
| K760652 | JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S | Pilling Co. | 1976-12-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04961333251766 | PENTAX Medical | HOYA CORPORATION | 2023-06-21 |
| 00860008795557 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics Inc | 2023-01-26 |
| 04048551417348 | n.a. | Karl Storz GmbH & Co. KG | 2020-03-02 |
| 00860002356006 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics Inc | 2019-12-17 |
| 00874485003210 | UNITY 9100 | COGENTIX MEDICAL, INC. | 2018-12-20 |
| 04048551047941 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551069677 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551047989 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551047996 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551048641 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551048658 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551053591 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551068762 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551068786 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551069615 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551069639 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551069653 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551047903 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551047897 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551047873 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551047866 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551047828 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551047811 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551047675 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551001974 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551001493 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551001387 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 00874485003005 | EndoSheath Technology | COGENTIX MEDICAL, INC. | 2016-09-23 |
| 00874485002985 | EndoSheath Technology | COGENTIX MEDICAL, INC. | 2016-09-23 |
| 20613994657828 | SLIDE-ON® | MEDTRONIC XOMED, INC. | 2016-05-13 |