Cleared Traditional

K954348 - GLANZ CARCINOMA GAUGE

K954348 is the FDA 510(k) clearance for GLANZ CARCINOMA GAUGE by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - EOB Nasopharyngoscope (flexible Or Rigid)

All 101
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K954348.
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
K961591 · Vision-Sciences, Inc. · Jul 1996
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH
K942265 · Vision-Sciences, Inc. · Dec 1995
OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS
K953771 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
FNL-10P, FIBER NASOPARHYNGOSCOPE
K951196 · Pentax Precision Instrument Corp. · Apr 1995
KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE
K951201 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
KARL STORZ TELE-SCRUB
K950334 · KARL STORZ Endoscopy-America, Inc. · Feb 1995