FDA 510(k)

ND Needle Guidance System

Número K: K262474 · 2026-07-27

Data da decisão2026-07-27

Código do produtoITX

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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