Data / Medical devices / Ireland / Phenox Limited

Phenox Limited: FDA-registered device maker in Galway Galway(County), Ireland, 7 510(k) clearances

Name: Phenox Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Phenox Limited is registered with the FDA (registration 3013656790) in Galway Galway(County), Ireland. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 15, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013656790
Address: Kamrick Court Ballybrit Business Park, Galway Galway(County), Ireland, H91XY38
Owner or operator: phenox Limited (10061667)
Roles: Complaint file establishment, Manufacturer
First device listed: November 7, 2019
Registered through: 2026
Brand names listed: Esperance pHLO Aspiration System, pNOVUS 21 Microcatheter, pORTAL Steerable Hydrophilic Guidewire, pRESET Delta LITE Thrombectomy Device, pRESET Delta Thrombectomy Device, pRESET LITE Thrombectomy Device, pRESET Thrombectomy Device

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Diagnostic	DQO	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Manufacturer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Guide, Wire, Catheter, Neurovasculature	MOF	2	Manufacturer	accessdata.fda.gov
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	POL	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Manufacturer	accessdata.fda.gov

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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 15, 2026	K251357	Esperance pHLO Aspiration System	NRY	Substantially Equivalent	Phenox, Ltd.	accessdata.fda.gov
February 28, 2025	K242676	pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device	POL	Substantially Equivalent	Phenox Limited	accessdata.fda.gov
November 12, 2024	K242420	pNOVUS 21 Microcatheter	DQO	Substantially Equivalent	Phenox, Ltd.	accessdata.fda.gov
October 21, 2023	K231539	pRESET LITE Thrombectomy Device	POL	Substantially Equivalent	Phenox Limited	accessdata.fda.gov
January 20, 2023	K222848	pRESET Thrombectomy Device	POL	Substantially Equivalent	Phenox Limited	accessdata.fda.gov
November 28, 2022	K221279	pNOVUS 21 Microcatheter	DQO	Substantially Equivalent	Phenox, Ltd.	accessdata.fda.gov
October 9, 2019	K191687	pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire	DQX	Substantially Equivalent	Phenox Limited	accessdata.fda.gov

Compare with other makers

Updated January 15, 2026. 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.