PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER— 510(k) K120261

Substantially Equivalent

Perouse Medical

FDA 510(k) clearance K120261 for PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER, Substantially Equivalent on 2012-05-02. Applicant: Perouse Medical.

Clearance details

Applicant: Perouse Medical
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2012-01-27
Decision date: 2012-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: France, FR

Download summary PDF View on FDA.gov ↗

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.