ClearanceBrief
Company ยท IE

Phenox Limited

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.

7510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment3
DQOCatheter, Intravascular, Diagnostic2
DQXWire, Guide, Catheter1
NRYCatheter, Thrombus Retriever1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 15, 2026K251357Esperance pHLO Aspiration System
Phenox, Ltd., IE
NRY
Feb 28, 2025K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
Phenox Limited, IE
POL
Nov 12, 2024K242420pNOVUS 21 Microcatheter
Phenox, Ltd., IE
DQO
Oct 21, 2023K231539pRESET LITE Thrombectomy Device
Phenox Limited, IE
POL
Jan 20, 2023K222848pRESET Thrombectomy Device
Phenox Limited, IE
POL
Nov 28, 2022K221279pNOVUS 21 Microcatheter
Phenox, Ltd., IE
DQO
Oct 9, 2019K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
Phenox Limited, IE
DQX

Latest recalls

DateFirm and productCodeLinked 510(k)
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