FDA.reportPublic FDA data

510(k) K250795

Device
PUREVUE? FMS
Applicant
W.O.M. World of Medicine GmbH
510(k) number
K250795
Product code
HRX
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-05
Date received
2025-03-14
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
No

Applicant Contact#

Contact
Soeren Markworth
Address
Salzufer 8 Berlin DE 10587 10587

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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