Cleared Traditional

VARIOUS TYPES OF LIGHT SOURCE HANDLES

K822257 · Kelleher Corp. · Ear, Nose, Throat

Oct 1982

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K822257 is an FDA 510(k) clearance for the VARIOUS TYPES OF LIGHT SOURCE HANDLES, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on October 26, 1982, 89 days after receiving the submission on July 29, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K822257 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 1982
Decision Date	October 26, 1982
Days to Decision	89 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).