FDA.reportPublic FDA data

Signum Surgical USA, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30381936983038193698Signum Surgical USA, Inc.1Y2026-01-01175 Strafford Ave Ste One Wayne PA US 19087

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3396111478568273DEN240007BioHealx Anal Fistula DeviceQML2024-07-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QML12024-07-01