Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)— 510(k) K240135
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K240135 for Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000), Substantially Equivalent on 2024-04-03. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- 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 allAdverse 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.