Phenox Inc
Galway Galway, IE
PHENOX INC appears in FDA device records in Galway Galway, IE. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Phenox Inc between 2019 and 2026. The busiest year on record is 2023, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251357 | Esperance pHLO Aspiration System | NRY | Substantially Equivalent | |
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | POL | Substantially Equivalent | |
| K242420 | pNOVUS 21 Microcatheter | DQO | Substantially Equivalent | |
| K231539 | pRESET LITE Thrombectomy Device | POL | Substantially Equivalent | |
| K222848 | pRESET Thrombectomy Device | POL | Substantially Equivalent | |
| K221279 | pNOVUS 21 Microcatheter | DQO | Substantially Equivalent | |
| K191687 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire | DQX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015543504 | 3015543504 | PHENOX INC | 9842 Research Drive, Irvine, CA 92618 US | 2026 | No device listings on this registration |
| 3013656790 | 3013656790 | PHENOX LIMITED | Kamrick Court, Galway Galway(County) H91XY38 IE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Phenox Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain