Esperance pHLO Aspiration System— 510(k) K251357

Name: FDA 510(k) clearance K251357
Creator: U.S. Food and Drug Administration
Published: 2026-01-15

Substantially Equivalent

Phenox, Ltd.

FDA 510(k) clearance K251357 for Esperance pHLO Aspiration System, Substantially Equivalent on 2026-01-15. Applicant: Phenox, Ltd.. Device class: 2.

Clearance details

Applicant: Phenox, Ltd.
Product code: Code NRY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2025-04-30
Decision date: 2026-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.