EOX · Esophagoscope (Flexible Or Rigid)
Ear, Nose, Throat · 21 CFR 874.4710 · Class 2
Overview
| Product Code | EOX |
|---|---|
| Device Name | Esophagoscope (Flexible Or Rigid) |
| Regulation | 21 CFR 874.4710 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.
Classification Rationale
Class II.
Cleared Devices (30)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | Jan 19, 2024 | SESE |
| K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | Feb 24, 2023 | SESK |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | Dec 2, 2022 | SESE |
| K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | Oct 26, 2022 | SESK |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | Capnostics, LLC | May 4, 2021 | SESE |
| K210137 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | Feb 18, 2021 | SESK |
| K192523 | CMOS Video Esophagoscope SSU | Karl Storz SE & CO. KG | Jan 24, 2020 | SESE |
| K183262 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics, Inc. | Jun 21, 2019 | SESK |
| K182159 | Strome-Blitzer Cytology Balloon | Adn International, LLC | Jun 13, 2019 | SESE |
| K181292 | PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor | Cogentix Medical, Inc. | Nov 15, 2018 | SESE |
| K181020 | Cytosponge Cell Collection Device | Covidien, LLC | Aug 16, 2018 | SESE |
| K152794 | Cytosponge Cell Collection Device | Covidien, LLC | Apr 12, 2016 | SESE |
| K142695 | Cytosponge Cell Collection Device | Covidien, LLC | Nov 26, 2014 | SESE |
| K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | Jun 21, 2013 | SESE |
| K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | Jun 20, 2012 | SESE |
| K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | Oct 21, 2011 | SESE |
| K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS | Vision-Sciences, Inc. | Aug 29, 2007 | SESE |
| K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | Vision-Sciences, Inc. | Aug 2, 2007 | SESE |
| K051972 | KARL STORZ TRANS-NASAL ESOPHAGOSCOPE | KARL STORZ Endoscopy-America, Inc. | Aug 15, 2005 | SESE |
| K031786 | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | Aug 5, 2003 | SESE |
| K953849 | PRISM ELECTROSCOPE | KARL STORZ Endoscopy-America, Inc. | Sep 6, 1995 | SESE |
| K951424 | M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM | M.E.R. Surgical Co. | May 9, 1995 | SESE |
| K951395 | KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES | KARL STORZ Endoscopy-America, Inc. | May 9, 1995 | SESE |
| K946331 | KARL STORZ BOUGIES, SOUNDS, DILATORS | KARL STORZ Endoscopy-America, Inc. | Mar 2, 1995 | SESE |
| K945237 | KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE | KARL STORZ Endoscopy-America, Inc. | Dec 21, 1994 | SESE |
| K943667 | ESOPHAGOSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Aug 18, 1994 | SESE |
| K934193 | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST | Biosearch Medical Products, Inc. | Nov 19, 1993 | SESE |
| K911588 | BRANDT ESOPHAGEAL CYTOLOGY BALLOON | Wilson-Cook Medical, Inc. | Nov 18, 1992 | SESE |
| K892259 | JESBERG ESOPHAGOSCOPE | Zinnanti Surgical Instruments, Inc. | Jun 16, 1989 | SESE |
| K760652 | JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S | Pilling Co. | Dec 16, 1976 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 6 clearances
- Lucid Diagnostics, Inc. — 4 clearances
- Vision-Sciences, Inc. — 3 clearances
- Intromedic Co., Ltd. — 3 clearances
- Covidien, LLC — 3 clearances
