Cleared Traditional

MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER

K940521 · Mill-Rose Laboratory · Ear, Nose, Throat

May 1994

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K940521 is an FDA 510(k) clearance for the MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC 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 May 4, 1994, 89 days after receiving the submission on February 4, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K940521 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 1994
Decision Date	May 04, 1994
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

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).