Cleared Traditional

K142695 - Cytosponge Cell Collection Device

K142695 is an FDA 510(k) clearance for Cytosponge Cell Collection Device, manufactured by Covidien, LLC. The device is a Class 2 Ear, Nose, Throat device with product code EOX cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K142695 · Covidien, LLC · Ear, Nose, Throat device
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Nov 2014
Decision
65d
Days
Class 2
Risk

K142695 is an FDA 510(k) clearance for the Cytosponge Cell Collection Device. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on November 26, 2014 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4710 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Covidien, LLC devices

FDA 510(k) Submission Details - K142695

510(k) Number K142695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date November 26, 2014
Days to Decision 65 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 89d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOX Device Classification - Class 2, Special Controls

Product Code EOX Esophagoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4710
Definition 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOX Esophagoscope (flexible Or Rigid)

All 25
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K142695.
PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
K181292 · Cogentix Medical, Inc. · Nov 2018
Cytosponge Cell Collection Device
K181020 · Covidien, LLC · Aug 2018
Cytosponge Cell Collection Device
K152794 · Covidien, LLC · Apr 2016
FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
K072088 · Vision-Sciences, Inc. · Aug 2007
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
K071903 · Vision-Sciences, Inc. · Aug 2007
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
K051972 · KARL STORZ Endoscopy-America, Inc. · Aug 2005