Signum Surgical USA, Inc.

FDA Device Registration & Listing · Wayne, PA, US · Registration 3038193698

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038193698
FEI Number
3038193698
Entity Name
Signum Surgical USA, Inc.
City/State/Country
Wayne, PA, US
Establishment Address
175 Strafford Ave Ste One, Wayne, PA 19087, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Signum Surgical Limited (Owner Number: 10092825)
Owner / Operator Contact Address
Signum Surgical Limited, New Docks, Port of Galway, Galway, IE-GA H91NNY6, IE
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
DEN240007
PMA Number
N/A

All Registered Proprietary Names

BioHealx Anal Fistula Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QML Anal Fistula Closure Device General, Plastic Surgery Class 2 878.4835 2025-02-23

Official Correspondent

Moshe Zilversmit

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Signum Surgical Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015615781 SIGNUM SURGICAL LIMITED Galway Galway (City), IE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038193698. Last updated year: 2026. Please use registration number 3038193698 when referencing this establishment in official correspondence.
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