Disposable Intraoperative Probe (DIOP8)— 510(k) K201425

Name: FDA 510(k) clearance K201425
Creator: U.S. Food and Drug Administration
Published: 2021-02-19

Substantially Equivalent

Huntleigh Healthcare Limited

FDA 510(k) clearance K201425 for Disposable Intraoperative Probe (DIOP8), Substantially Equivalent on 2021-02-19. Applicant: Huntleigh Healthcare Limited. Device class: 2.

Clearance details

Applicant: Huntleigh Healthcare Limited
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2020-05-29
Decision date: 2021-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cardiff, GB

Download summary PDF View on FDA.gov ↗

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K260161 — SmartGuide Disposable Guides and Grids2026-07-30
K262474 — ND Needle Guidance System2026-07-27
K261014 — Accuro® 3S Needle Guide Kit2026-07-24

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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 →

Recalls naming K201425

K-number listed on FDA's recall record

Z-0960-2022 — HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8Class II·Terminated·Huntleigh Healthcare Ltd.·20220211

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201425.

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