FDA 510(k)

Pytheas Your Guided Trajectory

Número K: K252880 · 2026-05-11

Data da decisão2026-05-11

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pytheas Your Guided Trajectory is the device name listed in this FDA 510(k) record. The listed applicant is Pytheas Navigation Sas. It received FDA 510(k) clearance on 2026-05-11 under 510(k) number K252880. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pytheas Your Guided Trajectory?

Pytheas Your Guided Trajectory is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Pytheas Navigation Sas. The 510(k) number is K252880.

When did Pytheas Your Guided Trajectory receive FDA 510(k) clearance?

Pytheas Your Guided Trajectory received FDA 510(k) clearance on 2026-05-11, under 510(k) number K252880.

Who is the listed applicant for Pytheas Your Guided Trajectory?

The FDA 510(k) record lists Pytheas Navigation Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pytheas Your Guided Trajectory?

The FDA product code for Pytheas Your Guided Trajectory is OLO.

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