Cleared Special

Single Use Guide Sheath Kit-401, K-402

K212667 · Olympus Medical Systems Corp. · Anesthesiology

Sep 2021

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K212667 is an FDA 510(k) clearance for the Single Use Guide Sheath Kit-401, K-402, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on September 22, 2021, 30 days after receiving the submission on August 23, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K212667 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2021
Decision Date	September 22, 2021
Days to Decision	30 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

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).