FDA.report

510(k) K253217

Device
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
Applicant
Medimaging Integrated Solution, Inc (Miis)
510(k) number
K253217
Product code
HRX
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-23
Date received
2025-09-29
Regulation
888.1100
Classification name
Arthroscope
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sandy Chou
Address
3f, # 24-2, Industry E. Rd. Iv, Hsinchu Science Park Hsinchu TW 30077 30077

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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