CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT— 510(k) K141749

Substantially Equivalent

Facet Technologies, LLC

FDA 510(k) clearance K141749 for CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT, Substantially Equivalent on 2014-07-29. Applicant: Facet Technologies, LLC.

Clearance details

Applicant: Facet Technologies, LLC
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2014-06-30
Decision date: 2014-07-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Kennesaw, GA, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.