FDA 510(k)

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range

N.º K: K171040 · 2017-07-31

SolicitanteKoelis

Fecha de decisión2017-07-31

Código de productoITX

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range is the device name listed in this FDA 510(k) record. The listed applicant is Koelis. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K171040. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range?

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Koelis. The 510(k) number is K171040.

When did Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range receive FDA 510(k) clearance?

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range received FDA 510(k) clearance on 2017-07-31, under 510(k) number K171040.

Who is the listed applicant for Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range?

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

What is the FDA product code for Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range?

The FDA product code for Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range is ITX.

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Otros registros que enlistan a Koelis como solicitante

K180970Disposable guides KDNG00 K170521TRINITY/3D PROSTATE SUITE K160357TRINITY

Dispositivos relacionados (Código: ITX)

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm Corporation K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLC K261014Kit de Guía de Aguja Accuro® 3SRivanna Medical, Inc.

Fuente oficial

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