SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4— 510(k) K904965

Substantially Equivalent

Smith & Nephew Equipment Group

FDA 510(k) clearance K904965 for SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4, Substantially Equivalent on 1991-01-16. Applicant: Smith & Nephew Equipment Group.

Clearance details

Applicant: Smith & Nephew Equipment Group
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 1990-11-05
Decision date: 1991-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.