Cleared Traditional

K012543 - VISION SCIENCES ENDOSHEATH SYSTEM

K012543 is the FDA 510(k) clearance for VISION SCIENCES ENDOSHEATH SYSTEM by Vision-Sciences, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K012543 · Vision-Sciences, Inc. · Ear, Nose, Throat device
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Jul 2002
Decision
342d
Days
Class 2
Risk

K012543 is an FDA 510(k) clearance for the VISION SCIENCES 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 July 15, 2002 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Vision-Sciences, Inc. devices

Submission Details

510(k) Number K012543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date July 15, 2002
Days to Decision 342 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 89d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K012543.
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