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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2024 | Lucid Diagnostics, Inc. Brand Name: EsophaCap
Product Name: EsophaCap (25mm diameter, 10 pores/inch)
Model/Catalog Number: EC25T10VI
Software Version: N/A
Product Description: EsophaCap is pouched as individual units. 10 un Open, Classified |
EOX | K203450 |
| May 24, 2024 | Lucid Diagnostics, Inc. Brand Name: EsophaCap
Product Name: EsophaCap (20mm diameter, 20 pores/inch)
Model/Catalog Number: EC20T20VI
Software Version: N/A
Product Description: EsophaCap is pouched as individual units. 10 un Open, Classified |
EOX | K203450 |
| Aug 2, 2023 | Covidien, LLC Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM Open, Classified |
EOX | K181020 |
| Aug 16, 2021 | Olympus Corporation of the Americas BF-XP60 OES Bronchofiberscope, Model No. BF-XP60 Terminated |
EOX | K023984 |
| Jun 6, 2016 | Covidien, LLC Covidien Cytosponge Cell Collection Device.
Item code CYTO-101-01.
Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the e Terminated |
EOX | K152794 |
| Jun 6, 2016 | Covidien, LLC Covidien Cytosponge Cell Collection Kit.
Contains Cytosponge Cell Collection Device, Specimen Jar with preservative.
Item code CYTO-KIT-R
Gastroenterology: Cytosponge Cell Collection Device is indic Terminated |
EOX | K152794 |
| Jan 20, 2012 | Pentax Medical Company EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK.
Intended to provide optical visualization (via a video monitor) of the Upper Airway. Terminated |
EOX | None listed |
| Jan 20, 2012 | Pentax Medical Company EE- Series Video Esophagoscopes, EE-1580K.
Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track. Terminated |
EOX | K961564 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.