Cleared Traditional

K934422 - NASOPHARYNGOSCOPE

K934422 is an FDA 510(k) clearance for NASOPHARYNGOSCOPE, manufactured by Marks & Murase. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K934422 · Marks & Murase · Ear, Nose, Throat device
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Jan 1994
Decision
136d
Days
Class 2
Risk

K934422 is an FDA 510(k) clearance for the NASOPHARYNGOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Marks & Murase (New York, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 136 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Marks & Murase devices

FDA 510(k) Submission Details - K934422

510(k) Number K934422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1993
Decision Date January 27, 1994
Days to Decision 136 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 89d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 106
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K934422.
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
K944296 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
K943665 · Olympus America, Inc. · Oct 1994
FORCEPS, PUNCHES, SCISSORS
K943074 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS
K933247 · Vision-Sciences, Inc. · Nov 1993
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K932988 · Smith & Nephew Richards, Inc. · Jul 1993
NASAL/PARANASAL ENDOSCOPE
K930931 · Storz Instrument Co. · May 1993