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FDA 510(k)

ND Needle Guidance System

K-Number: K262474 · 2026-07-27

ApplicantAccurate Access, LLC
Decision Date2026-07-27
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ND Needle Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Access, LLC. It received FDA 510(k) clearance on 2026-07-27 under 510(k) number K262474. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ND Needle Guidance System?

ND Needle Guidance System is a medical device that received FDA 510(k) clearance on 2026-07-27. The listed applicant is Accurate Access, LLC. The 510(k) number is K262474.

When did ND Needle Guidance System receive FDA 510(k) clearance?

ND Needle Guidance System received FDA 510(k) clearance on 2026-07-27, under 510(k) number K262474.

Who is the listed applicant for ND Needle Guidance System?

The FDA 510(k) record lists Accurate Access, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ND Needle Guidance System?

The FDA product code for ND Needle Guidance System is ITX.

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems CorporationK250762ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)Olympus Medical Systems CorporationK250524Mendaera Guidance SystemMendaera, Inc.K250469Accuro® 3S Needle Guide KitRivanna Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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