FDA 510(k)

Intuitive Endoluminal Gastrointestinal System (IG1000)

N.º K: K253702 · 2026-08-07

Fecha de decisión2026-08-07

Código de productoFDS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Intuitive Endoluminal Gastrointestinal System (IG1000) 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 2026-08-07 under 510(k) number K253702. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Intuitive Endoluminal Gastrointestinal System (IG1000)?

Intuitive Endoluminal Gastrointestinal System (IG1000) is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K253702.

¿Cuándo recibió el Sistema Gastrointestinal Endoluminal Intuitivo (IG1000) la aprobación FDA 510(k)?

Intuitive Endoluminal Gastrointestinal System (IG1000) received FDA 510(k) clearance on 2026-08-07, under 510(k) number K253702.

Who is the listed applicant for Intuitive Endoluminal Gastrointestinal System (IG1000)?

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 Intuitive Endoluminal Gastrointestinal System (IG1000)?

The FDA product code for Intuitive Endoluminal Gastrointestinal System (IG1000) is FDS.

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

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Dispositivos relacionados (Código: FDS)

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Fuente oficial

Ver en la base de datos de la FDA →

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