Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Phenox with 7 510(k) clearances. The most recent is a 510(k) clearance dated Jan 15, 2026: Esperance pHLO Aspiration System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 15, 2026 | Esperance pHLO Aspiration SystemK251357 · NRY | 510(k) clearances |
| Feb 28, 2025 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DeviceK242676 · POL | 510(k) clearances |
| Nov 12, 2024 | pNOVUS 21 MicrocatheterK242420 · DQO | 510(k) clearances |
| Oct 21, 2023 | pRESET LITE Thrombectomy DeviceK231539 · POL | 510(k) clearances |
| Jan 20, 2023 | pRESET Thrombectomy DeviceK222848 · POL | 510(k) clearances |
| Nov 28, 2022 | pNOVUS 21 MicrocatheterK221279 · DQO | 510(k) clearances |
| Oct 9, 2019 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WireK191687 · DQX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
