Cleared Special

K040018 - EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

K040018 is an FDA 510(k) clearance for EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, manufactured by Boston Scientific Corp. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Special 510(k) pathway after a 14-day FDA review.

K040018 · Boston Scientific Corp · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
14d
Days
Class 2
Risk

K040018 is an FDA 510(k) clearance for the EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on January 20, 2004 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040018

510(k) Number K040018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2004
Decision Date January 20, 2004
Days to Decision 14 days
Submission Type Special
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
76d faster than avg
Panel avg: 90d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

EOQ Device Classification - Class 2, Special Controls

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 243
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K040018.
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
K050907 · Fujinon, Inc. · May 2005
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
K050220 · Olympus Medical Systems Corporation · Feb 2005
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
K040940 · Olympus Corporation · Apr 2004
ENK FIBEROPTIC ATOMIZER SET
K031966 · Cook, Inc. · Oct 2003
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K033225 · Olympus Optical Co., Ltd. · Oct 2003
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
K022446 · Aomori Olympus Co., Ltd. · Mar 2003
K040018 · EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
Download PDF FDA Summary Boston Scientific Corp