K222801

Substantially Equivalent

Safety Lancet

Applicant: Sarstedt AG & CO KG
Product code: FMK
Advisory panel: General, Plastic Surgery
Date received: 2022-09-16
Decision date: 2023-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nuembrecht, DE

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.