CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT— 510(k) K140568

Substantially Equivalent

Facet Technologies, LLC

FDA 510(k) clearance K140568 for CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT, Substantially Equivalent on 2014-05-13. Applicant: Facet Technologies, LLC.

Clearance details

Applicant: Facet Technologies, LLC
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2014-03-05
Decision date: 2014-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

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.