Esophagoscope (Flexible Or Rigid)
FDA product code EOX · Class II (moderate risk) · 21 CFR 874.4710 · Ear, Nose, Throat
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).
30510(k) clearances
0PMA approvals
8recalls
Manufacturers
- KARL STORZ Endoscopy-America, Inc. 6
- Lucid Diagnostics, Inc. 4
- Vision-Sciences, Inc. 3
- Intromedic Co., Ltd. 3
- Covidien LLC 3
- Pilling Co. 1
- Zinnanti Surgical Instruments, Inc. 1
- Wilson-Cook Medical, Inc. 1
- Biosearch Medical Products, Inc. 1
- M.E.R. Surgical Co. 1
- Cogentix Medical, Inc. 1
- Adn International, LLC 1
- Karl Storz SE & CO. KG 1
- Capnostics, LLC 1
- Pentax of America, Inc. 1
- Cyted Limited 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233142 | EndoSign® Cell collection device (ES-CYT-102)EOX · Traditional | Cyted Limited | 01/19/2024SE |
| K230339 | EsoCheck Cell Collection DeviceEOX · Special | Lucid Diagnostics, Inc. | 02/24/2023SESK |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10EOX · Traditional | Pentax of America, Inc. | 12/02/2022SE |
| K222366 | EsoCheck Cell Collection DeviceEOX · Traditional | Lucid Diagnostics, Inc. | 10/26/2022SESK |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)EOX · Traditional | Capnostics, LLC | 05/04/2021SE |
| K210137 | EsoCheck Cell Collection DeviceEOX · Special | Lucid Diagnostics, Inc. | 02/18/2021SESK |
| K192523 | CMOS Video Esophagoscope SSUEOX · Traditional | Karl Storz SE & CO. KG | 01/24/2020SE |
| K183262 | EsoCheck CCD Cell Collection DeviceEOX · Traditional | Lucid Diagnostics, Inc. | 06/21/2019SESK |
| K182159 | Strome-Blitzer Cytology BalloonEOX · Traditional | Adn International, LLC | 06/13/2019SE |
| K181292 | PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video ProcessorEOX · Traditional | Cogentix Medical, Inc. | 11/15/2018SE |
| K181020 | Cytosponge Cell Collection DeviceEOX · Traditional | Covidien, LLC | 08/16/2018SE |
| K152794 | Cytosponge Cell Collection DeviceEOX · Traditional | Covidien, LLC | 04/12/2016SE |
| K142695 | Cytosponge Cell Collection DeviceEOX · Traditional | Covidien, LLC | 11/26/2014SE |
| K131131 | E.G. Scan(Tm) II Esophagoscope SystemEOX · Special | Intromedic Co., Ltd. | 06/21/2013SE |
| K120702 | E.G. Scan II Esphagoscope SystemEOX · Traditional | Intromedic Co., Ltd. | 06/20/2012SE |
| K111030 | E.G. Scan (TM) Esophagoscope SystemEOX · Traditional | Intromedic Co., Ltd. | 10/21/2011SE |
| K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…EOX · Special | Vision-Sciences, Inc. | 08/29/2007SE |
| K071903 | Endosheath Systems for Use with Vision-Sciences Tne ScopeEOX · Special | Vision-Sciences, Inc. | 08/02/2007SE |
| K051972 | Karl Storz Trans-Nasal EsophagoscopeEOX · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/15/2005SE |
| K031786 | TNE-2000 Esophagoscope with Ecs-D Endosheath SystemEOX · Traditional | Vision-Sciences, Inc. | 08/05/2003SE |
| K953849 | Prism ElectroscopeEOX · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/06/1995SE |
| K951424 | M. E. R. Surgical Co. Omin Instrument SystemEOX · Traditional | M.E.R. Surgical Co. | 05/09/1995SE |
| K951395 | Karl Storz ENT Needles, Tonsil Syringes & NeedlesEOX · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/09/1995SE |
| K946331 | Karl Storz Bougies, Sounds, DilatorsEOX · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/02/1995SE |
| K945237 | Karl Storz Suctyion/Irrigation Tubes, CannulaeEOX · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/21/1994SE |
| K943667 | Esophagoscope and AccessoriesEOX · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/18/1994SE |
| K934193 | Cell-Mate(Tm) Mass Cytology-Cellular Retrieval SystEOX · Traditional | Biosearch Medical Products, Inc. | 11/19/1993SE |
| K911588 | Brandt Esophageal Cytology BalloonEOX · Traditional | Wilson-Cook Medical, Inc. | 11/18/1992SE |
| K892259 | Jesberg EsophagoscopeEOX · Traditional | Zinnanti Surgical Instruments, Inc. | 06/16/1989SE |
| K760652 | Jesberg Esophagoscopes W/Austinetic S SEOX · Traditional | Pilling Co. | 12/16/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1900-2024 Class II | Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch)…The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from… | Lucid Diagnostics, Inc. | 04/24/2024Open, Classified |
| Z-1899-2024 Class II | Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch)…The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from… | Lucid Diagnostics, Inc. | 04/24/2024Open, Classified |
| Z-2282-2023 Class II | Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell…Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of… | Covidien, LLC | 06/02/2023Open, Classified |
| Z-2566-2021 Class II | BF-XP60 OES Bronchofiberscope, Model No. BF-XP60The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance… | Olympus Corporation of the Americas | 08/16/2021Terminated |
| Z-2123-2016 Class II | Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology:…Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the… | Covidien, LLC | 06/06/2016Terminated |
| Z-2122-2016 Class II | Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device…Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the… | Covidien, LLC | 06/06/2016Terminated |
| Z-0820-2012 | EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK. Intended to provide optical…The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the… | Pentax Medical Company | 09/30/2011Terminated |
| Z-0819-2012 | EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of…The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the… | Pentax Medical Company | 09/30/2011Terminated |