Cleared Special

K023376 - EB-1830T3, VIDEO BRONCHOSCOPE
(FDA 510(k) Clearance)

K023376 · Pentax Precision Instrument Corp. · Ear, Nose, Throat

Oct 2002

Decision

Days

Class 2

Risk

K023376 is an FDA 510(k) clearance for the EB-1830T3, VIDEO BRONCHOSCOPE, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on October 16, 2002, 8 days after receiving the submission on October 8, 2002. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K023376 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 2002
Decision Date	October 16, 2002
Days to Decision	8 days
Submission Type	Special
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).