Cleared Traditional

NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS (K943665) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943665 · Olympus America, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Oct 1994
Decision
75d
Days
Class 2
Risk

K943665 is an FDA 510(k) clearance for the NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on October 11, 1994 after a review of 75 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 Olympus America, Inc. devices

Submission Details

510(k) Number K943665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date October 11, 1994
Days to Decision 75 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
14d faster than avg
Panel avg: 89d · This submission: 75d
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 62
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K943665.
KARL STORZ INSULATED SCISSORS
K944298 · KARL STORZ Endoscopy-America, Inc. · Nov 1994
KARL STORZ INSULATED CANNULAE, SUCTION TUBES
K944797 · KARL STORZ Endoscopy-America, Inc. · Nov 1994
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
K944296 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
FORCEPS, PUNCHES, SCISSORS
K943074 · KARL STORZ Endoscopy-America, Inc. · Aug 1994