Cleared Traditional

Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga (K163537) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163537 · Covidien, LLC · Ear, Nose, Throat device
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Apr 2017
Decision
126d
Days
Class 2
Risk

K163537 is an FDA 510(k) clearance for the Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Covidien, LLC (Plymouth, US). The FDA issued a Cleared decision on April 21, 2017 after a review of 126 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 Covidien, LLC devices

Submission Details

510(k) Number K163537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date April 21, 2017
Days to Decision 126 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
37d slower than avg
Panel avg: 89d · This submission: 126d
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 140
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K163537.
Captura Disposable Bronchoscope Biopsy Forceps
K163377 · Wilson-Cook Medical, Inc. · Feb 2018
FUJIFILM Bronchoscope Model EB-530P
K171291 · Fujifilm Medical Systems U.S.A, Inc. · Jan 2018
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
K173554 · Pentax of America, Inc. · Jan 2018
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
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
K142934 · Covidien · Jun 2015