Cleared Special

K100125 - VISION SCIENCES FLEXIBLE ENT SCOPE

K100125 is an FDA 510(k) clearance for VISION SCIENCES FLEXIBLE ENT SCOPE, manufactured by Vision-Sciences, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Special 510(k) pathway after a 37-day FDA review.

K100125 · Vision-Sciences, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
37d
Days
Class 2
Risk

K100125 is an FDA 510(k) clearance for the VISION SCIENCES FLEXIBLE ENT SCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Orangeburg, US). The FDA issued a Cleared decision on February 25, 2010 after a review of 37 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

FDA 510(k) Submission Details - K100125

510(k) Number K100125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2010
Decision Date February 25, 2010
Days to Decision 37 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
53d faster than avg
Panel avg: 90d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

EOB Device Classification - Class 2, Special Controls

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 122
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K100125.
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K082569 · Entellus Medical, Inc. · Sep 2008
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K072387 · KARL STORZ Endoscopy-America, Inc. · Sep 2007