Cleared Special

K050972 - VISION-SCIENCES ENT-3000 SCOPE

K050972 is the FDA 510(k) clearance for VISION-SCIENCES ENT-3000 SCOPE by Vision-Sciences, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Special 510(k) pathway after a 11-day FDA review.

K050972 · Vision-Sciences, Inc. · Ear, Nose, Throat device
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Apr 2005
Decision
11d
Days
Class 2
Risk

K050972 is an FDA 510(k) clearance for the VISION-SCIENCES ENT-3000 SCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Ayer, US). The FDA issued a Cleared decision on April 29, 2005 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - 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 K050972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date April 29, 2005
Days to Decision 11 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 89d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
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 - EOB Nasopharyngoscope (flexible Or Rigid)

All 83
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K050972.
KSEA MINIATURE ENDOSCOPE, MODEL 11565
K070752 · KARL STORZ Endoscopy-America, Inc. · May 2007
MICROENDOSCOPE
K063078 · Acclarent, Inc. · Oct 2006
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K052452 · Olympus Medical Systems Corporation · Sep 2005
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · Olympus America, Inc. · May 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · KARL STORZ Endoscopy-America, Inc. · Jan 2002
KSEA UNIMAT 12
K002700 · KARL STORZ Endoscopy-America, Inc. · Oct 2000