FDA.reportPublic FDA data

GI WINDOWS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30219693263021969326GI WINDOWS1N2026-01-01480 Neponset St Ste 11b1 Canton MA US 02021

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3285621127759560K253550Self-Forming Magnet (Flexagon Plus OTOLoc)SAH2026-01-09
3285621194187862K243482Self-Forming Magnet (Flexagon)SAH2025-06-11
3285621053403422

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SAH22026-01-09

PMN#