Cleared Traditional

K200702 - EasyPath RF Introducer Sheath (FDA 510(k) Clearance)

K200702 · Broncus Medical, Inc. · Ear, Nose, Throat device

Jan 2021

Decision

302d

Days

Class 2

Risk

K200702 is an FDA 510(k) clearance for the EasyPath RF Introducer Sheath. This device is classified as a Bronchoscope (flexible Or Rigid) (Class II - Special Controls, product code EOQ).

Submitted by Broncus Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on January 14, 2021, 302 days after receiving the submission on March 18, 2020.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. 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)..

Submission Details

510(k) Number	K200702 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 18, 2020
Decision Date	January 14, 2021
Days to Decision	302 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
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).