FDA.reportPublic FDA data

510(k) K232435

Device
Rhinolaryngoscope system
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
510(k) number
K232435
Product code
EOB
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-26
Date received
2023-08-14
Regulation
874.4760
Classification name
Nasopharyngoscope (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 Shi
Address
415, 416-1,516-1, Bldg. 2, # 1, Mawu Rd., Baoan Community, Yuanshan St., Longgang Shenzhen CN 518100 518100

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EOB#

510(k), Device, Applicant table
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K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.2022-09-19
K214050ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis)2022-07-01