Cleared Traditional

MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES

K023984 · The Olympus Optical Co. · Ear, Nose, Throat

Jan 2003

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K023984 is an FDA 510(k) clearance for the MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on January 31, 2003, 60 days after receiving the submission on December 2, 2002. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K023984 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2002
Decision Date	January 31, 2003
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOQ — Bronchoscope (flexible Or Rigid)
Device Class	Class II — 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).