Bronchoscope System
FDA 510(k) K211169 · Shanghai AnQing Medical Instrument Co., Ltd.
510(k) numberK211169
Submission
- Device name
- Bronchoscope System
- Applicant
- Shanghai AnQing Medical Instrument Co., Ltd.
Shanghai, CN - Received
- April 19, 2021
- Decision date
- November 24, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
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…
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| K260382 | MONARCH Platform (MON-000008)EOQ · Traditional | Auris Health, Inc. | 07/25/2026SE |
| K254037 | LungFlow Airway CatheterEOQ · Traditional | Free Flow Medical, Inc. | 07/10/2026SE |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | Fujifilm Corporation | 06/16/2026SE |
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| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)EOQ · Traditional | MacroLux Medical Technology Co., Ltd. | 04/08/2026SE |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710USEOQ · Traditional | Fujifilm Corporation | 12/12/2025SE |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | Karl Storz SE & CO. KG | 12/05/2025SE |
| K252045 | Ion Endoluminal System (IF1000)EOQ · Traditional | Intuitive Surgical, Inc. | 09/23/2025SE |
More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23)HIH · Traditional | 02/26/2026SE |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…FGB · Special | 10/03/2025SE |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Special | 09/15/2025SE |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)EOQ · Traditional | 08/27/2025SE |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…EOQ · Traditional | 05/29/2025SE |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)FGB · Traditional | 04/11/2025SE |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)FBN · Traditional | 10/17/2023SE |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Traditional | 11/09/2022SE |
| K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)FGB · Special | 10/05/2022SE |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model:…FGB · Traditional | 08/26/2022SE |
Questions and answers
When was Bronchoscope System cleared by the FDA?
Bronchoscope System (K211169) received a 510(k) decision of Substantially Equivalent on November 24, 2021, 219 days after the submission was received.
What is the product code of K211169?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.