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.

Summary

Accurate Access's ND Needle Guidance System is filed under ITX, diagnostic ultrasonic transducers. The record doesn't expand "ND" or list the system's components.

Class II, 21 CFR 892.1570. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).

Accurate Access filed from Paradise Valley, Arizona. Review took 10 calendar days (July 17 to July 27, 2026).

Clearance details

Applicant: Accurate Access, LLC
Product code: Product 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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K260114 — Align® Cover and Pad Guidance Tool2026-09-24
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

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.