Data / Medical devices / Ireland / Signum Surgical Limited

Signum Surgical Limited: FDA-registered device maker in Galway Galway(City), Ireland, 1 510(k) clearance

Signum Surgical Limited is registered with the FDA (registration 3015615781) in Galway Galway(City), Ireland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 1, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3015615781

Address

Signum Surgical Limited New Docks, Port of Galway, Galway Galway(City), Ireland, H91NNY6

Owner or operator

Signum Surgical Limited (10092825)

Roles

Complaint file establishment, Repackager or relabeler, Specification developer

First device listed

February 23, 2025

Registered through

2026

Brand names listed

BioHealx Anal Fistula Device

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Updated July 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.