Cleared Traditional

MILL-ROSE PULMONARY FORCEPS

K922204 · Mill-Rose Laboratory · Ear, Nose, Throat

Jul 1993

Decision

428d

Days

Class 2

Risk

About This 510(k) Submission

K922204 is an FDA 510(k) clearance for the MILL-ROSE PULMONARY FORCEPS, 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 July 13, 1993, 428 days after receiving the submission on May 11, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K922204 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 1992
Decision Date	July 13, 1993
Days to Decision	428 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).