ND Needle Guidance System— 510(k) K262474

Name: FDA 510(k) clearance K262474
Creator: U.S. Food and Drug Administration
Published: 2026-07-27

Substantially Equivalent

Accurate Access, LLC

FDA 510(k) clearance K262474 for ND Needle Guidance System, Substantially Equivalent on 2026-07-27. Applicant: Accurate Access, LLC. Device class: 2.

Clearance details

Applicant: Accurate Access, LLC
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2026-07-17
Decision date: 2026-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paradise Valley, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITX

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K261170 — BA-004CC2026-08-12
K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
K260161 — SmartGuide Disposable Guides and Grids2026-07-30
K261014 — Accuro® 3S Needle Guide Kit2026-07-24
K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)2025-09-18

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 →

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