Panels › Ear, Nose, Throat › Product code EOX · Class 2
Esophagoscope (Flexible Or Rigid)
Regulation 874.4710
0510(k)s in 12 months (30 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in EOX
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien, LLC | 3 | 3 |
| KARL STORZ Endoscopy-America, Inc. | 6 | 0 |
| Lucid Diagnostics, Inc. | 4 | 2 |
| Intromedic Co., Ltd. | 3 | 0 |
| Vision-Sciences, Inc. | 3 | 0 |
| Pentax Medical Company | 0 | 2 |
| Adn International, LLC | 1 | 0 |
| Biosearch Medical Products, Inc. | 1 | 0 |
| Capnostics, LLC | 1 | 0 |
| Cogentix Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 19, 2024 | K233142 | EndoSign® Cell collection device (ES-CYT-102) Cyted Limited, GB | EOX |
| Feb 24, 2023 | K230339 | EsoCheck Cell Collection Device Lucid Diagnostics, Inc. | EOX |
| Dec 2, 2022 | K223072 | PENTAX Medical Video Esophagoscope EE17-J10 Pentax of America, Inc. | EOX |
| Oct 26, 2022 | K222366 | EsoCheck Cell Collection Device Lucid Diagnostics, Inc. | EOX |
| May 4, 2021 | K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) Capnostics, LLC | EOX |
| Feb 18, 2021 | K210137 | EsoCheck Cell Collection Device Lucid Diagnostics, Inc. | EOX |
| Jan 24, 2020 | K192523 | CMOS Video Esophagoscope SSU Karl Storz SE & CO. KG, DE | EOX |
| Jun 21, 2019 | K183262 | EsoCheck CCD Cell Collection Device Lucid Diagnostics, Inc. | EOX |
| Jun 13, 2019 | K182159 | Strome-Blitzer Cytology Balloon Adn International, LLC | EOX |
| Nov 15, 2018 | K181292 | PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor Cogentix Medical, Inc. | EOX |
| Aug 16, 2018 | K181020 | Cytosponge Cell Collection Device Covidien, LLC | EOX |
| Apr 12, 2016 | K152794 | Cytosponge Cell Collection Device Covidien, LLC | EOX |
| Nov 26, 2014 | K142695 | Cytosponge Cell Collection Device Covidien, LLC | EOX |
| Jun 21, 2013 | K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM Intromedic Co., Ltd. | EOX |
| Jun 20, 2012 | K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM Intromedic Co., Ltd., KR | EOX |
| Oct 21, 2011 | K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM Intromedic Co., Ltd., KR | EOX |
| Aug 29, 2007 | K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS Vision-Sciences, Inc. | EOX |
| Aug 2, 2007 | K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE Vision-Sciences, Inc. | EOX |
| Aug 15, 2005 | K051972 | KARL STORZ TRANS-NASAL ESOPHAGOSCOPE KARL STORZ Endoscopy-America, Inc. | EOX |
| Aug 5, 2003 | K031786 | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM Vision-Sciences, Inc. | EOX |
| Sep 6, 1995 | K953849 | PRISM ELECTROSCOPE KARL STORZ Endoscopy-America, Inc. | EOX |
| May 9, 1995 | K951424 | M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM M.E.R. Surgical Co. | EOX |
| May 9, 1995 | K951395 | KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES KARL STORZ Endoscopy-America, Inc. | EOX |
| Mar 2, 1995 | K946331 | KARL STORZ BOUGIES, SOUNDS, DILATORS KARL STORZ Endoscopy-America, Inc. | EOX |
| Dec 21, 1994 | K945237 | KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE KARL STORZ Endoscopy-America, Inc. | EOX |
| Aug 18, 1994 | K943667 | ESOPHAGOSCOPE AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. | EOX |
| Nov 19, 1993 | K934193 | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST Biosearch Medical Products, Inc. | EOX |
| Nov 18, 1992 | K911588 | BRANDT ESOPHAGEAL CYTOLOGY BALLOON Wilson-Cook Medical, Inc. | EOX |
| Jun 16, 1989 | K892259 | JESBERG ESOPHAGOSCOPE Zinnanti Surgical Instruments, Inc. | EOX |
| Dec 16, 1976 | K760652 | JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S Pilling Co. | EOX |
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