FDA.report

510(k) K243020

Device
MIDASVu
Applicant
Intravu, Inc.
510(k) number
K243020
Product code
HRX
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-02
Date received
2024-09-27
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
Jenna Rapoport
Address
610 Price Ave. Redwood City CA US 94063 94063

FDA Registration Numbers

Source Documents

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

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