PIGALILEO 4TH GENERATION SYSTEM— 510(k) K080875

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K080875 for PIGALILEO 4TH GENERATION SYSTEM, Substantially Equivalent on 2008-07-18. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2008-03-31
Decision date: 2008-07-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Memphis, TN, US

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.