Cleared Special

K072073 - VISION-SCIENCES ENT-5000 AND ENT-5100 V...

K072073 is the FDA 510(k) clearance for VISION-SCIENCES ENT-5000 AND ENT-5100 V... 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 30-day FDA review.

K072073 · Vision-Sciences, Inc. · Ear, Nose, Throat device
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Aug 2007
Decision
30d
Days
Class 2
Risk

K072073 is an FDA 510(k) clearance for the VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM,.... 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 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 874.4760 - 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 K072073 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
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 89d · This submission: 30d
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 K072073.
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K110097 · Acclarent, Inc. · May 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577 · Acclarent, Inc. · Jan 2011
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K072387 · KARL STORZ Endoscopy-America, Inc. · Sep 2007
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