EOX · Class II · 21 CFR 874.4710

FDA Product Code EOX: Esophagoscope (flexible Or Rigid)

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).

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Lucid Diagnostics, Inc. and Vision-Sciences, Inc..

30
Total
30
Cleared
109d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 4 in the prior period

FDA 510(k) Cleared Esophagoscope (flexible Or Rigid) Devices (Product Code EOX)

30 devices
1–24 of 30
Cleared Jan 19, 2024
EndoSign® Cell collection device (ES-CYT-102)
K233142
Cyted Limited
Gastroenterology & Urology · 114d
Cleared Feb 24, 2023
EsoCheck Cell Collection Device
K230339
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 17d
Cleared Dec 02, 2022
PENTAX Medical Video Esophagoscope EE17-J10
K223072
Pentax of America, Inc.
Ear, Nose, Throat · 63d
Cleared Oct 26, 2022
EsoCheck Cell Collection Device
K222366
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 83d
Cleared May 04, 2021
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
K203450
Capnostics, LLC
Gastroenterology & Urology · 162d
Cleared Feb 18, 2021
EsoCheck Cell Collection Device
K210137
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 24, 2020
CMOS Video Esophagoscope SSU
K192523
Karl Storz SE & CO. KG
Ear, Nose, Throat · 133d
Cleared Jun 21, 2019
EsoCheck CCD Cell Collection Device
K183262
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 210d
Cleared Jun 13, 2019
Strome-Blitzer Cytology Balloon
K182159
Adn International, LLC
Gastroenterology & Urology · 308d
Cleared Nov 15, 2018
PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
K181292
Cogentix Medical, Inc.
Ear, Nose, Throat · 183d
Cleared Aug 16, 2018
Cytosponge Cell Collection Device
K181020
Covidien, LLC
Gastroenterology & Urology · 121d
Cleared Apr 12, 2016
Cytosponge Cell Collection Device
K152794
Covidien, LLC
Ear, Nose, Throat · 197d
Cleared Nov 26, 2014
Cytosponge Cell Collection Device
K142695
Covidien, LLC
Ear, Nose, Throat · 65d
Cleared Aug 29, 2007
FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
K072088
Vision-Sciences, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 02, 2007
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
K071903
Vision-Sciences, Inc.
Ear, Nose, Throat · 23d
Cleared Aug 15, 2005
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
K051972
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 05, 2003
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
K031786
Vision-Sciences, Inc.
Ear, Nose, Throat · 56d
Cleared Sep 06, 1995
PRISM ELECTROSCOPE
K953849
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 21d
Cleared May 09, 1995
KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES
K951395
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 42d
Cleared Mar 02, 1995
KARL STORZ BOUGIES, SOUNDS, DILATORS
K946331
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 63d
Cleared Dec 21, 1994
KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE
K945237
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Aug 18, 1994
ESOPHAGOSCOPE AND ACCESSORIES
K943667
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 19, 1993
CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST
K934193
Biosearch Medical Products, Inc.
Ear, Nose, Throat · 85d
Cleared Nov 18, 1992
BRANDT ESOPHAGEAL CYTOLOGY BALLOON
K911588
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 589d

About Product Code EOX - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code EOX since 1976, with 30 receiving FDA clearance (average review time: 109 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.