Cleared Traditional

K963426 - KARL STORZ CONTACT MICRO-LARYNGOSCOPES

K963426 is an FDA 510(k) clearance for KARL STORZ CONTACT MICRO-LARYNGOSCOPES, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K963426 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
69d
Days
Class 2
Risk

K963426 is an FDA 510(k) clearance for the KARL STORZ CONTACT MICRO-LARYNGOSCOPES. 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 7, 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K963426

510(k) Number K963426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1996
Decision Date November 07, 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
21d faster than avg
Panel avg: 90d · This submission: 69d
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 128
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K963426.
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · Smith & Nephew, Inc. · Mar 1997
GALILEO ENDOSCOPES
K962116 · Galileo Electro-Optics Corp. · Nov 1996
IRRIGATION/SUCTION HANDLE AND SHEATH
K963757 · Richard Wolf Medical Instruments Corp. · Nov 1996
CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
K962255 · Clarus Medical Systems, Inc. · Sep 1996
KSEA BIPOLAR GOAGULATING FORCEPS
K962396 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
KSEA UNIMAT PLUS
K962898 · KARL STORZ Endoscopy-America, Inc. · Aug 1996