FDA 510(k)

KARL STORZ ICG Imaging System with RUBINA® Lens

N.º K: K254242 · 2026-02-26

Fecha de decisión2026-02-26

Código de productoOWN

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

KARL STORZ ICG Imaging System with RUBINA® Lens is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K254242. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the KARL STORZ ICG Imaging System with RUBINA® Lens?

KARL STORZ ICG Imaging System with RUBINA® Lens is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K254242.

When did KARL STORZ ICG Imaging System with RUBINA® Lens receive FDA 510(k) clearance?

KARL STORZ ICG Imaging System with RUBINA® Lens received FDA 510(k) clearance on 2026-02-26, under 510(k) number K254242.

Who is the listed applicant for KARL STORZ ICG Imaging System with RUBINA® Lens?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ ICG Imaging System with RUBINA® Lens?

The FDA product code for KARL STORZ ICG Imaging System with RUBINA® Lens is OWN.

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Otros registros que enlistan a Karl Storz SE & CO. KG como solicitante

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)K254303KARL STORZ SUPRALOOP K261102UNIDRIVE Select System K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)K260884UNIDRIVE Select System K254103HOPKINS Telescopes for Arthroscopy

Ver todos los 33 dispositivos →

Dispositivos relacionados (Código: OWN)

K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG K260108L12 LED Light Source with AIMStryker Endoscopy

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.