Universal Mesh - Sterile— 510(k) K182425
Substantially EquivalentStryker Leibinger GmbH & Co KG
FDA 510(k) clearance K182425 for Universal Mesh - Sterile, Substantially Equivalent on 2018-11-06. Applicant: Stryker Leibinger GmbH & Co KG.
Clearance details
- Applicant
- Stryker Leibinger GmbH & Co KG
- Product code
- Code GWO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Freiburg, DE
Adverse events under product code GWO
product code GWO- Malfunction
- 583
- Total
- 583
Source: openFDA MAUDE database, through . 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.