VS3-IR— 510(k) K191851

Substantially Equivalent

Medtronic

FDA 510(k) clearance K191851 for VS3-IR, Substantially Equivalent on 2019-11-25. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Product code: Code OWN
Advisory panel: Gastroenterology, Urology
Date received: 2019-07-10
Decision date: 2019-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petach Tikva, Hamerkaz, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

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.