FDA 510(k)

SILKBridge

Número K: K260245 · 2026-04-09

Data da decisão2026-04-09

Código do produtoJXI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SILKBridge is the device name listed in this FDA 510(k) record. The listed applicant is KLISBio S.r.l.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K260245. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SILKBridge?

SILKBridge is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is KLISBio S.r.l.. The 510(k) number is K260245.

When did SILKBridge receive FDA 510(k) clearance?

SILKBridge received FDA 510(k) clearance on 2026-04-09, under 510(k) number K260245.

Who is the listed applicant for SILKBridge?

The FDA 510(k) record lists KLISBio S.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILKBridge?

The FDA product code for SILKBridge is JXI.

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