FDA 510(k)

da Vinci SP SureForm 45 Staplers and Reloads (SP1098)

N.º K: K243596 · 2025-03-10

Fecha de decisión2025-03-10

Código de productoGAG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

da Vinci SP SureForm 45 Staplers and Reloads (SP1098) is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-03-10 under 510(k) number K243596. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the da Vinci SP SureForm 45 Staplers and Reloads (SP1098)?

da Vinci SP SureForm 45 Staplers and Reloads (SP1098) is a medical device that received FDA 510(k) clearance on 2025-03-10. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K243596.

When did da Vinci SP SureForm 45 Staplers and Reloads (SP1098) receive FDA 510(k) clearance?

da Vinci SP SureForm 45 Staplers and Reloads (SP1098) received FDA 510(k) clearance on 2025-03-10, under 510(k) number K243596.

Who is the listed applicant for da Vinci SP SureForm 45 Staplers and Reloads (SP1098)?

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

What is the FDA product code for da Vinci SP SureForm 45 Staplers and Reloads (SP1098)?

The FDA product code for da Vinci SP SureForm 45 Staplers and Reloads (SP1098) is GAG.

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Otros registros que enlistan a Intuitive Surgical, Inc. como solicitante

K261823da Vinci Surgical System, Model IS5000 K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000 K261249Universal Seal (5-12 mm)K253986Instrumentos de Retroalimentación Táctil da Vinci K253978Universal Seal (5-12 mm)

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Dispositivos relacionados (Código: GAG)

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Fuente oficial

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