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FDA 510(k)

SILKBridge

K-Number: K260245 · 2026-04-09

ApplicantKLISBio S.r.l.
Decision Date2026-04-09
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the SILKBridge?

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

When was SILKBridge approved by the FDA?

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

What company makes SILKBridge?

SILKBridge is manufactured by KLISBio S.r.l..

What is the FDA product code for SILKBridge?

The FDA product code for SILKBridge is JXI.

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Official Source

View on FDA Database →

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

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