Cleared Traditional

K910536 - PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER
(FDA 510(k) Clearance)

K910536 · Mill-Rose Laboratory · Ear, Nose, Throat

Sep 1991

Decision

228d

Days

Class 2

Risk

K910536 is an FDA 510(k) clearance for the PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on September 24, 1991, 228 days after receiving the submission on February 8, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K910536 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 1991
Decision Date	September 24, 1991
Days to Decision	228 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

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).