FDA 510(k)

Intuitive Endoluminal Gastrointestinal System (IG1000)

K-Number: K253702 · 2026-08-07

Decision Date2026-08-07

Product CodeFDS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

When did Intuitive Endoluminal Gastrointestinal System (IG1000) receive FDA 510(k) clearance?

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.

Related Clinical Trials

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Other records listing Intuitive Surgical, Inc. as applicant

K261824da Vinci Surgical System, Model IS5000 K261249Universal Seal (5-12 mm)K260695da Vinci Firefly Imaging System 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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Related Devices (Code: FDS)

K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm Corporation K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc.K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.