PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606— 510(k) K041919

Substantially Equivalent

Clinico

FDA 510(k) clearance K041919 for PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606, Substantially Equivalent on 2004-10-04. Applicant: Clinico.

Clearance details

Applicant: Clinico
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2004-07-16
Decision date: 2004-10-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bad Hersfeld, DE

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.