Cleared Special

K071903 - ENDOSHEATH SYSTEMS FOR USE WITH VISION-...

K071903 is the FDA 510(k) clearance for ENDOSHEATH SYSTEMS FOR USE WITH VISION-... by Vision-Sciences, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOX) cleared through the Special 510(k) pathway after a 23-day FDA review.

K071903 · Vision-Sciences, Inc. · Ear, Nose, Throat device
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Aug 2007
Decision
23d
Days
Class 2
Risk

K071903 is an FDA 510(k) clearance for the ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE. 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 2, 2007 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vision-Sciences, Inc. devices

Submission Details

510(k) Number K071903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2007
Decision Date August 02, 2007
Days to Decision 23 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 K071903.
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KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
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