Cleared Traditional

Captura Disposable Bronchoscope Biopsy Forceps

K163377 · Wilson-Cook Medical, Inc. · Ear, Nose, Throat

Feb 2018

Decision

447d

Days

Class 2

Risk

About This 510(k) Submission

K163377 is an FDA 510(k) clearance for the Captura Disposable Bronchoscope Biopsy Forceps, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Wilson-Cook Medical, Inc. (Winstrom-Salem, US). The FDA issued a Cleared decision on February 21, 2018, 447 days after receiving the submission on December 1, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K163377 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2016
Decision Date	February 21, 2018
Days to Decision	447 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).