Cleared Special

K072088 - FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS

K072088 is an FDA 510(k) clearance for FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOP..., manufactured by Vision-Sciences, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOX cleared through the Special 510(k) pathway after a 30-day FDA review.

K072088 · Vision-Sciences, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
30d
Days
Class 2
Risk

K072088 is an FDA 510(k) clearance for the FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DIS.... 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 29, 2007 after a review of 30 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

FDA 510(k) Submission Details - K072088

510(k) Number K072088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2007
Decision Date August 29, 2007
Days to Decision 30 days
Submission Type Special
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
60d faster than avg
Panel avg: 90d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 28
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K072088.
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
K131131 · Intromedic Co., Ltd. · Jun 2013
E.G. SCAN II ESPHAGOSCOPE SYSTEM
K120702 · Intromedic Co., Ltd. · Jun 2012
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
K111030 · Intromedic Co., Ltd. · Oct 2011
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
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
K031786 · Vision-Sciences, Inc. · Aug 2003