Cleared Traditional

K954797 - KARL STORZ RHINO-LARYNGO-BRONCHO FIBERS...

K954797 is the FDA 510(k) clearance for KARL STORZ RHINO-LARYNGO-BRONCHO FIBERS... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K954797 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
91d
Days
Class 2
Risk

K954797 is an FDA 510(k) clearance for the KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K954797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1995
Decision Date January 17, 1996
Days to Decision 91 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
2d slower than avg
Panel avg: 89d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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 - EOQ Bronchoscope (flexible Or Rigid)

All 182
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K954797.
KARL STORZ INTUBATION FIBERSCOPE
K961178 · KARL STORZ Endoscopy-America, Inc. · May 1996
MILL-ROSE BLIND MICROBIOLOGY BRUSH
K960880 · Mill-Rose Laboratory · Apr 1996
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
K960791 · KARL STORZ Endoscopy-America, Inc. · Mar 1996
SAUER ENDOSCOPE GUIDE AND INTUBATION AID
K954125 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
DISTENDING DIVERTICULOSCOPE
K953596 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
JEDMED LARYNGEAL SCOPE
K950925 · Jedmed Instrument Co. · Aug 1995