FDA.reportPublic FDA data

510(k) K222910

Device
Bronchoscope System
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
510(k) number
K222910
Product code
EOQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-11
Date received
2022-09-26
Regulation
874.4680
Classification name
Bronchoscope (Flexible Or Rigid)
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cathy S
Address
416-1, 516-1, Bldg. 2, # 1, Mawu Rd., Baoan Community, Yuanshan St., Longgang District Shenzhen CN 518100 518100

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EOQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.2026-04-08
K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation2025-12-12
K251731KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)Karl Storz SE & CO. KG2025-12-05
K251894Himaging Bronchscope SystemHimaging Technology (Shanghai) Co., Ltd.2025-09-23
K252045Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.2025-09-23
K252528Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.2025-09-05
K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.2025-08-27