Cleared Traditional

K943700 - KARL STORZ BRONCHOSCOPE ACCESSORIES

K943700 is the FDA 510(k) clearance for KARL STORZ BRONCHOSCOPE ACCESSORIES 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 25-day FDA review.

K943700 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
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Aug 1994
Decision
25d
Days
Class 2
Risk

K943700 is an FDA 510(k) clearance for the KARL STORZ BRONCHOSCOPE ACCESSORIES. 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 August 23, 1994 after a review of 25 days - a notably fast clearance cycle.

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: 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 K943700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1994
Decision Date August 23, 1994
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
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 181
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K943700.
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K931442 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
MILL-ROSE HARRELL BRONCHIAL BRUSH
K944649 · Mill-Rose Laboratory · Nov 1994
WANG BRONCHIAL NEEDLE BRUSH
K944650 · Mill-Rose Laboratory · Nov 1994
RICHARD ROD LENS LARYNGOSCOPE
K941264 · Smith & Nephew Richards, Inc. · Jul 1994
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER
K940521 · Mill-Rose Laboratory · May 1994
VB-1830/VB-1530, VIDEO BRONCHOSCOPE
K934920 · Pentax Precision Instrument Corp. · Jan 1994