Cleared Traditional

K954348 - GLANZ CARCINOMA GAUGE, KSEA (FDA 510(k) Clearance)

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

K954348 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Nov 1995
Decision
58d
Days
Class 2
Risk

K954348 is an FDA 510(k) clearance for the GLANZ CARCINOMA GAUGE, KSEA. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on November 15, 1995 after a review of 58 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K954348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date November 15, 1995
Days to Decision 58 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
31d faster than avg
Panel avg: 89d · This submission: 58d
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.

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All 159
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