Bronchoscope System
K-Number: K211169 · 2021-11-24
Decision Date2021-11-24
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Bronchoscope System is a medical device manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-11-24 under approval number K211169. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bronchoscope System?
Bronchoscope System is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K211169.
When was Bronchoscope System approved by the FDA?
Bronchoscope System received FDA 510(k) clearance on 2021-11-24, under approval number K211169.
What company makes Bronchoscope System?
Bronchoscope System is manufactured by Shanghai AnQing Medical Instrument Co., Ltd..
What is the FDA product code for Bronchoscope System?
The FDA product code for Bronchoscope System is EOQ.
Other Devices by Shanghai AnQing Medical Instrument Co., Ltd.
K180367Ureterorenoscope System
K181545Hysteroscope System
K201293Ureterorenoscope System
K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
Related Devices (Code: EOQ)
K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView MonitorAmbu A/S
K152319Auris Robotic Endoscopy System (ARES)Auris Surgical Robotics, Inc.
K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)Prosurg, Inc.
K171492B7 2C Occlusion BalloonSpiration, Inc.
K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC
K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.