Cleared Traditional

Rescue Pulmonary Grasping Forceps

K202987 · Anrei Medical (Hangzhou) Co., Ltd. · Anesthesiology

Apr 2021

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K202987 is an FDA 510(k) clearance for the Rescue Pulmonary Grasping Forceps, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Anrei Medical (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 29, 2021, 211 days after receiving the submission on September 30, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K202987 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2020
Decision Date	April 29, 2021
Days to Decision	211 days
Submission Type	Traditional
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).