K253702
- 510(k) number
- K253702
- Device name
- Intuitive Endoluminal Gastrointestinal System (IG1000)
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-08-07
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253702.pdf
Official FDA record: K253702
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.