IntelliCartTM System— 510(k) K162421

Name: FDA 510(k) clearance K162421
Creator: U.S. Food and Drug Administration
Published: 2016-12-21

Substantially Equivalent

Dornoch Medical Systems

FDA 510(k) clearance K162421 for IntelliCartTM System, Substantially Equivalent on 2016-12-21. Applicant: Dornoch Medical Systems. Device class: 2.

Clearance details

Applicant: Dornoch Medical Systems
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2016-08-30
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Riverside, MO, US

Download summary PDF View on FDA.gov ↗

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K190789 — IntelliCartTM System2019-04-24
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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.