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FDA 510(k)

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer

N.º K: K250314 · 2025-12-19

SolicitanteSurgical Instrument Service and Savings, Inc.
Fecha de decisión2025-12-19
Código de productoPNE
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K250314. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer?

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K250314.

When did Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer received FDA 510(k) clearance on 2025-12-19, under 510(k) number K250314.

Who is the listed applicant for Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer?

The FDA product code for Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer is PNE.

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Dispositivos relacionados (Código: PNE)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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