MICROJET QUARK, MODEL U100 OR U40— 510(k) K013807

Substantially Equivalent

Cane S.R.L.

FDA 510(k) clearance K013807 for MICROJET QUARK, MODEL U100 OR U40, Substantially Equivalent on 2001-12-12. Applicant: Cane S.R.L..

Clearance details

Applicant: Cane S.R.L.
Product code: Code LZG
Advisory panel: General Hospital
Date received: 2001-11-15
Decision date: 2001-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

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Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

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.