Ion Endoluminal System— 510(k) K192367

Name: FDA 510(k) clearance K192367
Creator: U.S. Food and Drug Administration
Published: 2019-11-26

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K192367 for Ion Endoluminal System, Substantially Equivalent on 2019-11-26. 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: 2019-08-30
Decision date: 2019-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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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.