FDA 510(k)

Intuitive Endoluminal Gastrointestinal System (IG1000)

K-번호: K253702 · 2026-08-07

결정일2026-08-07

제품 코드FDS

자문 위원회GU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Intuitive Endoluminal Gastrointestinal System (IG1000)이 언제 FDA 510(k) 인정을 받았는가요?

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.

Intuitive Surgical, Inc.를 신청인으로 등재한 기타 기록

K261823da Vinci Surgical System, Model IS5000 K261824da Vinci Surgical System, Model IS5000 K261249Universal Seal (5-12 mm)K253986da Vinci Force Feedback Instruments K253978Universal Seal (5-12 mm)K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator

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