510(k) K013890— SURGICAL DYNAMICS MENISCAL STAPLE

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2001-11-23
Decision date: 2001-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwalk, CT, US

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.