FDA 510(k)

Prana System

N.º K: K253405 · 2026-04-01

Fecha de decisión2026-04-01

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Prana System is the device name listed in this FDA 510(k) record. The listed applicant is Prana Surgical. It received FDA 510(k) clearance on 2026-04-01 under 510(k) number K253405. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Prana System?

Prana System is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Prana Surgical. The 510(k) number is K253405.

When did Prana System receive FDA 510(k) clearance?

Prana System received FDA 510(k) clearance on 2026-04-01, under 510(k) number K253405.

Who is the listed applicant for Prana System?

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

What is the FDA product code for Prana System?

The FDA product code for Prana System is GEI.

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