K935753

Substantially Equivalent

THE GRAFTOLOGER

Applicant: Neoligaments, Ltd.
Product code: HWE
Advisory panel: General, Plastic Surgery
Date received: 1993-11-26
Decision date: 1994-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, GB

Adverse events under product code HWE

product code HWE

Death: 4
Injury: 448
Malfunction: 19,856
Other: 2
Total: 20,310

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.