Ion Endoluminal System (IF1000)— 510(k) K252045
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K252045 for Ion Endoluminal System (IF1000), Substantially Equivalent on 2025-09-23. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Product code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code EOQ
view allMore clearances from Intuitive Surgical, Inc.
view all- K263592 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
- K262455 — da Vinci 5 Handheld Camera Head (470080) +4 more
- K261823 — da Vinci Surgical System, Model IS5000
- K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)
- K261824 — da Vinci Surgical System, Model IS5000
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.