Cleared Traditional

Esperance pHLO Aspiration System

K251357 · Phenox, Ltd. · Neurology

Jan 2026

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K251357 is an FDA 510(k) clearance for the Esperance pHLO Aspiration System, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Phenox, Ltd. (Galway, IE). The FDA issued a Cleared decision on January 15, 2026, 260 days after receiving the submission on April 30, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K251357 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2025
Decision Date	January 15, 2026
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.