FDA 510(k)

PK AIM

N.º K: K170908 · 2017-05-19

Fecha de decisión2017-05-19

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PK AIM is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K170908. 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 PK AIM?

PK AIM is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K170908.

When did PK AIM receive FDA 510(k) clearance?

PK AIM received FDA 510(k) clearance on 2017-05-19, under 510(k) number K170908.

Who is the listed applicant for PK AIM?

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

What is the FDA product code for PK AIM?

The FDA product code for PK AIM is GEI.

Otros registros que enlistan a Gyrus Acmi, Inc. como solicitante

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.

K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)K231327POWERSEAL Sealer and Divider K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories K212650Celeris, Disposable Sinus Debrider K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

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Fuente oficial

Ver en la base de datos de la FDA →

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