Cleared Traditional

K061313 - EVIS EXERA 180 SYSTEM

K061313 is the FDA 510(k) clearance for EVIS EXERA 180 SYSTEM by Olympus Medical Systems Corporation. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K061313 · Olympus Medical Systems Corporation · Ear, Nose, Throat device
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Aug 2006
Decision
113d
Days
Class 2
Risk

K061313 is an FDA 510(k) clearance for the EVIS EXERA 180 SYSTEM. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on August 31, 2006 after a review of 113 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K061313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2006
Decision Date August 31, 2006
Days to Decision 113 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
24d slower than avg
Panel avg: 89d · This submission: 113d
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 178
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K061313.
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
K121035 · Fujifilm Medical System U.S.A., Inc. · Jun 2012
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
K082720 · Olympus Medical Systems Corporation · Nov 2008
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
K071530 · KARL STORZ Endoscopy-America, Inc. · Aug 2007
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
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · Boston Scientific Corp · Jan 2004