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FDA 510(k)

Excelsior System

K-Number: K253291 · 2026-01-20

ApplicantBlue Ocean Global
Decision Date2026-01-20
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Excelsior System is a medical device manufactured by Blue Ocean Global. It received FDA 510(k) clearance on 2026-01-20 under approval number K253291. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Excelsior System?

Excelsior System is a medical device that received FDA 510(k) clearance on 2026-01-20. It is manufactured by Blue Ocean Global. The 510(k) number is K253291.

When was Excelsior System approved by the FDA?

Excelsior System received FDA 510(k) clearance on 2026-01-20, under approval number K253291.

What company makes Excelsior System?

Excelsior System is manufactured by Blue Ocean Global.

What is the FDA product code for Excelsior System?

The FDA product code for Excelsior System is KTT.

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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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