Cleared Traditional

K082720 - TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 (FDA 510(k) Clearance)

K082720 · Olympus Medical Systems Corporation · Ear, Nose, Throat device

Nov 2008

Decision

49d

Days

Class 2

Risk

K082720 is an FDA 510(k) clearance for the TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005. This device is classified as a Bronchoscope (flexible Or Rigid) (Class II - Special Controls, product code EOQ).

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on November 5, 2008, 49 days after receiving the submission on September 17, 2008.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. 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)..

Submission Details

510(k) Number	K082720 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 17, 2008
Decision Date	November 05, 2008
Days to Decision	49 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).