Cleared Traditional

Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V

K221631 · Olympus Medical Systems Corp. · Ear, Nose, Throat

Sep 2022

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K221631 is an FDA 510(k) clearance for the Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Olympus Medical Systems Corp. (Tokyo, JP). The FDA issued a Cleared decision on September 26, 2022, 112 days after receiving the submission on June 6, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K221631 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2022
Decision Date	September 26, 2022
Days to Decision	112 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).