Cleared Traditional

K142934 - CrossCountry Transbronchial Access Tool...

K142934 is the FDA 510(k) clearance for CrossCountry Transbronchial Access Tool... by Covidien. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K142934 · Covidien · Ear, Nose, Throat device
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Jun 2015
Decision
251d
Days
Class 2
Risk

K142934 is an FDA 510(k) clearance for the CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial.... Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Covidien (Plymouth, US). The FDA issued a Cleared decision on June 17, 2015 after a review of 251 days - an extended review 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: 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 Covidien devices

Submission Details

510(k) Number K142934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2014
Decision Date June 17, 2015
Days to Decision 251 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 89d · This submission: 251d
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 149
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K142934.
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
K163537 · Covidien, LLC · Apr 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K163248 · Boston Scientific Corporation · Mar 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151315 · Boston Scientific Corporation · Nov 2015
GenCut Core Biopsy System
K142839 · Covidien, LLC · Apr 2015
EVIS EXERA III VIDEO SYSTEM
K121959 · Olympus Medical Systems Corp. · Jan 2013
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
K122535 · Fujifilm Medical System U.S.A., Inc. · Dec 2012