Inessa System— 510(k) K230545

Name: FDA 510(k) clearance K230545
Creator: U.S. Food and Drug Administration
Published: 2023-12-20

Substantially Equivalent

Triple Jump Israel , Ltd.

FDA 510(k) clearance K230545 for Inessa System, Substantially Equivalent on 2023-12-20. Applicant: Triple Jump Israel , Ltd.. Device class: 2.

Clearance details

Applicant: Triple Jump Israel , Ltd.
Product code: Code QFG
Device class: Class 2
Regulation: 21 CFR 880.5730
Advisory panel: Clinical Chemistry
Date received: 2023-02-28
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Lllit, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QFG

product code QFG

Death: 228
Injury: 118,915
Malfunction: 1,001,752
Other: 7
Total: 1,120,902

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.