FDA.reportPublic FDA data

SONEX HEALTH, Inc

Matched from indexed company URL: Sonex Health

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134798473013479847SONEX HEALTH, Inc1N2026-01-01950 Blue Gentian Road Suite 200 Eagan MN US 55121

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860002094700SX-One MicroKnife - SX-One MicroKnife is rebranded as UltraGuideCTR. UltraGuideCTR is intended to transect the transverse carpal ligament for the treatment of carpal tunnel syndrome.UltraGuideCTR is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.888-518-8780customerservice@sonexhealth.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2018191892348720K252594UltraGuideCTR® image guided soft tissue release systemHRX2025-09-29
2018192050541490

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRX12025-09-29

PMN#

GUDID#