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. Device class: 2.
Clearance details
- Applicant
- Stryker Leibinger GmbH & Co KG
- Product code
- Code GWO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Freiburg, DE
Recent devices under product code GWO
view allMore clearances from Stryker Leibinger GmbH & Co KG
view allAdverse 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 →
Recalls naming K182425
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182425.
Data sourced from openFDA. This site is unofficial and independent of the FDA.