FDA 510(k)

Intuitive Endoluminal Gastrointestinal System (IG1000)

Número K: K253702 · 2026-08-07

Data da decisão2026-08-07

Código do produtoFDS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Quando o Sistema Gastrointestinal Endoluminal Intuitivo (IG1000) recebeu a aprovação 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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Fonte oficial

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