SOLOPAK BRAND FILTER NEEDLE W/5 MICRO— 510(k) K841280

Substantially Equivalent

Smith & Nephew, Mpl Division

FDA 510(k) clearance K841280 for SOLOPAK BRAND FILTER NEEDLE W/5 MICRO, Substantially Equivalent on 1984-05-21. Applicant: Smith & Nephew, Mpl Division.

Clearance details

Applicant: Smith & Nephew, Mpl Division
Product code: Code FPB
Advisory panel: General Hospital
Date received: 1984-03-28
Decision date: 1984-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

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.