FDA 510(k)

CN-Suite™

Número K: K260563 · 2026-08-16

RequerenteFIND Surgical Sciences Inc. D/B/A FIND Neuro

Data da decisão2026-08-16

Código do produtoOLX

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

CN-Suite™ is the device name listed in this FDA 510(k) record. The listed applicant is FIND Surgical Sciences Inc. D/B/A FIND Neuro. It received FDA 510(k) clearance on 2026-08-16 under 510(k) number K260563. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CN-Suite™?

CN-Suite™ is a medical device that received FDA 510(k) clearance on 2026-08-16. The listed applicant is FIND Surgical Sciences Inc. D/B/A FIND Neuro. The 510(k) number is K260563.

When did CN-Suite™ receive FDA 510(k) clearance?

CN-Suite™ received FDA 510(k) clearance on 2026-08-16, under 510(k) number K260563.

Who is the listed applicant for CN-Suite™?

The FDA 510(k) record lists FIND Surgical Sciences Inc. D/B/A FIND Neuro as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CN-Suite™?

The FDA product code for CN-Suite™ is OLX.

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Fonte oficial

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