Cleared Traditional

K961591 - DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIB...

K961591 is the FDA 510(k) clearance for DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIB... 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 69-day FDA review.

K961591 · Vision-Sciences, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
69d
Days
Class 2
Risk

K961591 is an FDA 510(k) clearance for the DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Natick, US). The FDA issued a Cleared decision on July 2, 1996 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vision-Sciences, Inc. devices

Submission Details

510(k) Number K961591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1996
Decision Date July 02, 1996
Days to Decision 69 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
20d faster than avg
Panel avg: 89d · This submission: 69d
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 K961591.
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K963426 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
KSEA BIPOLAR GOAGULATING FORCEPS
K962396 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
KSEA UNIMAT PLUS
K962898 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS
K953771 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
GLANZ CARCINOMA GAUGE, KSEA
K954348 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
FNL-10P, FIBER NASOPARHYNGOSCOPE
K951196 · Pentax Precision Instrument Corp. · Apr 1995