Cleared Traditional

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

K213235 · Pentax of America, Inc. · Ear, Nose, Throat

Dec 2022

Decision

447d

Days

Class 2

Risk

About This 510(k) Submission

K213235 is an FDA 510(k) clearance for the PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on December 21, 2022, 447 days after receiving the submission on September 30, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K213235 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2021
Decision Date	December 21, 2022
Days to Decision	447 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).