Cleared Special

K050972 - VISION-SCIENCES ENT-3000 SCOPE

K050972 is an FDA 510(k) clearance for VISION-SCIENCES ENT-3000 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 11-day FDA review.

K050972 · Vision-Sciences, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K050972

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 90d · This submission: 11d
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 162
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K050972.
MICROENDOSCOPE
K063078 · Acclarent, Inc. · Oct 2006
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES
K061663 · Rtc Inc.-Memcath Technologies, LLC · Sep 2006
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K052452 · Olympus Medical Systems Corporation · Sep 2005
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K040984 · Vision-Sciences, Inc. · Apr 2004
ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
K032822 · Asap Endoscopic Products GmbH · Jan 2004
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES
K030857 · Mahe Intl., Inc. · Oct 2003
K050972 · VISION-SCIENCES ENT-3000 SCOPE
Download PDF Vision-Sciences, Inc.