ON CALL CHOSEN LANCING DEVICE— 510(k) K113332

Substantially Equivalent

ACON Laboratories, Inc.

FDA 510(k) clearance K113332 for ON CALL CHOSEN LANCING DEVICE, Substantially Equivalent on 2012-04-18. Applicant: ACON Laboratories, Inc..

Clearance details

Applicant: ACON Laboratories, Inc.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2011-11-14
Decision date: 2012-04-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Diego, CA, US

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.