Cleared Traditional

WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE

K914181 · Mill-Rose Laboratory · Ear, Nose, Throat

Dec 1991

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K914181 is an FDA 510(k) clearance for the WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE, 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 December 10, 1991, 83 days after receiving the submission on September 18, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K914181 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 1991
Decision Date	December 10, 1991
Days to Decision	83 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).