Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)— 510(k) K212048

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K212048 for Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe), Substantially Equivalent on 2021-08-26. Applicant: Intuitive Surgical, Inc..

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2021-06-30
Decision date: 2021-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.