Cleared Traditional

K963757 - IRRIGATION/SUCTION HANDLE AND SHEATH

K963757 is the FDA 510(k) clearance for IRRIGATION/SUCTION HANDLE AND SHEATH by Richard Wolf Medical Instruments Corp.. 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.

K963757 · Richard Wolf Medical Instruments Corp. · Ear, Nose, Throat device
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Nov 1996
Decision
69d
Days
Class 2
Risk

K963757 is an FDA 510(k) clearance for the IRRIGATION/SUCTION HANDLE AND SHEATH. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on November 26, 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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K963757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1996
Decision Date November 26, 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
Combination Product No
PCCP Authorized No
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 86
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K963757.
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K972855 · KARL STORZ Endoscopy-America, Inc. · Sep 1997
SHARPSITE AC
K965233 · Xomed, Inc. · Apr 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · Smith & Nephew, Inc. · Mar 1997
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