510(k) K152794
- Device
- Cytosponge Cell Collection Device
- Applicant
- Covidien LLC
- 510(k) number
- K152794
- Product code
- EOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-04-12
- Date received
- 2015-09-28
- Regulation
- 874.4710
- Classification name
- Esophagoscope (flexible Or Rigid)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Clare Santulli
- Address
- 15 Hampshire St. Mansfield MA US 02040 02040
FDA Registration Numbers#
- 9681384
- 9681572
- 3006546082
- 3012322232
- 3008439484
- 3014605202
- 3003761012
- 3007244127
- 3004644065
- 9614434
- 3005465238
- 3015925378
- 3014328942
- 3009217531
- 1221826
- 9611616
- 9610877
- 3025482817
- 3013684328
- 3005382983
- 3042889296
- 3010707607
- 9610617
- 3003782610
- 3004904811
- 3010202439
- 9612501
- 3018094310
- 2020550
- 3004180226
- 3014342096
- 3016490370
- 1048735
- 3011137372
- 3013944123
- 3023852420
- 1045254
- 2242464
- 3010041511
- 3015865915
Source Documents#
Other 510(k) Records For Product Code EOX #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases