FDA Product Code
FDA Product Code EOX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4710
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | 2024-01-19 | Traditional | PDF ↗ |
| K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2023-02-24 | Special | PDF ↗ |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | 2022-12-02 | Traditional | PDF ↗ |
| K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2022-10-26 | Traditional | PDF ↗ |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | Capnostics, LLC | 2021-05-04 | Traditional | PDF ↗ |
| K210137 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2021-02-18 | Special | PDF ↗ |
| K192523 | CMOS Video Esophagoscope SSU | Karl Storz SE & CO. KG | 2020-01-24 | Traditional | PDF ↗ |
| K183262 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics, Inc. | 2019-06-21 | Traditional | PDF ↗ |
| K182159 | Strome-Blitzer Cytology Balloon | Adn International, LLC | 2019-06-13 | Traditional | PDF ↗ |
| K181292 | PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor | Cogentix Medical, Inc. | 2018-11-15 | Traditional | PDF ↗ |
| K181020 | Cytosponge Cell Collection Device | Covidien, LLC | 2018-08-16 | Traditional | PDF ↗ |
| K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016-04-12 | Traditional | PDF ↗ |
| K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014-11-26 | Traditional | PDF ↗ |
| K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2013-06-21 | Special | PDF ↗ |
| K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2012-06-20 | Traditional | PDF ↗ |
| K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2011-10-21 | Traditional | PDF ↗ |
| K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS | Vision-Sciences, Inc. | 2007-08-29 | Special | PDF ↗ |
| K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | Vision-Sciences, Inc. | 2007-08-02 | Special | PDF ↗ |
| K051972 | KARL STORZ TRANS-NASAL ESOPHAGOSCOPE | KARL STORZ Endoscopy-America, Inc. | 2005-08-15 | Traditional | PDF ↗ |
| K031786 | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 2003-08-05 | Traditional | PDF ↗ |
| K953849 | PRISM ELECTROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1995-09-06 | Traditional | PDF ↗ |
| K951424 | M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM | M.E.R. Surgical Co. | 1995-05-09 | Traditional | PDF ↗ |
| K951395 | KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES | KARL STORZ Endoscopy-America, Inc. | 1995-05-09 | Traditional | PDF ↗ |
| K946331 | KARL STORZ BOUGIES, SOUNDS, DILATORS | KARL STORZ Endoscopy-America, Inc. | 1995-03-02 | Traditional | PDF ↗ |
| K945237 | KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE | KARL STORZ Endoscopy-America, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K943667 | ESOPHAGOSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1994-08-18 | Traditional | PDF ↗ |
| K934193 | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST | Biosearch Medical Products, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K911588 | BRANDT ESOPHAGEAL CYTOLOGY BALLOON | Wilson-Cook Medical, Inc. | 1992-11-18 | Traditional | PDF ↗ |
| K892259 | JESBERG ESOPHAGOSCOPE | Zinnanti Surgical Instruments, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K760652 | JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S | Pilling Co. | 1976-12-16 | Traditional | PDF ↗ |
Product code EOX · Class II · Ear, Nose, Throat. Data: openFDA.