Cleared Traditional

K071530 - KARL STORZ VIDEO FLEXIBLE VIDEO ENT END...

K071530 is the FDA 510(k) clearance for KARL STORZ VIDEO FLEXIBLE VIDEO ENT END... 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 80-day FDA review.

K071530 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 2007
Decision
80d
Days
Class 2
Risk

K071530 is an FDA 510(k) clearance for the KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM. 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 24, 2007 after a review of 80 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 K071530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2007
Decision Date August 24, 2007
Days to Decision 80 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
9d faster than avg
Panel avg: 89d · This submission: 80d
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 K071530.
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
K121035 · Fujifilm Medical System U.S.A., Inc. · Jun 2012
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
K091768 · Vision-Sciences, Inc. · Aug 2009
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
K082720 · Olympus Medical Systems Corporation · Nov 2008
EVIS EXERA 180 SYSTEM
K061313 · Olympus Medical Systems Corporation · Aug 2006
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
K060243 · Olympus Medical Systems Corporation · Jun 2006
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
K050220 · Olympus Medical Systems Corporation · Feb 2005