FDA.reportPublic FDA data

510(k) K213697

Device
ORiGO System
Applicant
Bien-Air Surgery SA
510(k) number
K213697
Product code
HBC
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-31
Date received
2021-11-23
Regulation
882.4360
Classification name
Motor, Drill, Electric
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jonas Guerdat
Address
Rue De L'Ouest 2b Le Noirmont CH 2340 2340

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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