FDA.reportPublic FDA data

INSIGHT MEDICAL SYSTEMS, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30198786583019878658INSIGHT MEDICAL SYSTEMS, INC1N2026-01-019801 Metric Boulevard Austin TX US 78758

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3462781801993200K243950ARVIS® ShoulderSBF2025-01-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SBF12025-01-13