Intuitive Endoluminal Gastrointestinal System (IG1000)— 510(k) K253702
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K253702 for Intuitive Endoluminal Gastrointestinal System (IG1000), Substantially Equivalent on 2026-08-07. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Code FDS
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code FDS
view all- K260573 — EvoEndo Single-Use Endoscopy System
- K250550 — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
- K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
- K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
- K251041 — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
More clearances from Intuitive Surgical, Inc.
view allAdverse events under product code FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.