FDA 510(k)

Plenity

N.º K: K230133 · 2024-01-19

Fecha de decisión2024-01-19

Código de productoQFQ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Plenity is the device name listed in this FDA 510(k) record. The listed applicant is Gelesis, Inc.. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K230133. The device is classified under product code QFQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Plenity?

Plenity is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Gelesis, Inc.. The 510(k) number is K230133.

When did Plenity receive FDA 510(k) clearance?

Plenity received FDA 510(k) clearance on 2024-01-19, under 510(k) number K230133.

Who is the listed applicant for Plenity?

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

What is the FDA product code for Plenity?

The FDA product code for Plenity is QFQ.

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Fuente oficial

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