Cleared Traditional

MODEL FBS-1, FLEXIBLE BRONCHOSCOPE

K811181 · American Optical Corp. · Ear, Nose, Throat

May 1981

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K811181 is an FDA 510(k) clearance for the MODEL FBS-1, FLEXIBLE BRONCHOSCOPE, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1981, 15 days after receiving the submission on April 28, 1981. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K811181 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1981
Decision Date	May 13, 1981
Days to Decision	15 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).