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FDA 510(k)

Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)

N.º K: K231872 · 2023-08-25

SolicitanteKirwan Surgical Products, LLC
Fecha de decisión2023-08-25
Código de productoGEI
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) is the device name listed in this FDA 510(k) record. The listed applicant is Kirwan Surgical Products, LLC. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K231872. 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 Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)?

Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Kirwan Surgical Products, LLC. The 510(k) number is K231872.

When did Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) receive FDA 510(k) clearance?

Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) received FDA 510(k) clearance on 2023-08-25, under 510(k) number K231872.

Who is the listed applicant for Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)?

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

What is the FDA product code for Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)?

The FDA product code for Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) is GEI.

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Dispositivos relacionados (Código: GEI)

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Fuente oficial

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