Cleared Traditional

K031786 - TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOS...

K031786 is the FDA 510(k) clearance for TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOS... by Vision-Sciences, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOX) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K031786 · Vision-Sciences, Inc. · Ear, Nose, Throat device
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Aug 2003
Decision
56d
Days
Class 2
Risk

K031786 is an FDA 510(k) clearance for the TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Ayer, US). The FDA issued a Cleared decision on August 5, 2003 after a review of 56 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 Vision-Sciences, Inc. devices

Submission Details

510(k) Number K031786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2003
Decision Date August 05, 2003
Days to Decision 56 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 89d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 22
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K031786.
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K051972 · KARL STORZ Endoscopy-America, Inc. · Aug 2005
PRISM ELECTROSCOPE
K953849 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
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K951395 · KARL STORZ Endoscopy-America, Inc. · May 1995
KARL STORZ BOUGIES, SOUNDS, DILATORS
K946331 · KARL STORZ Endoscopy-America, Inc. · Mar 1995