PolypVac Microdebrider (3.3mm and 4.0mm)— 510(k) K161101
Substantially EquivalentLaurimed, LLC
FDA 510(k) clearance K161101 for PolypVac Microdebrider (3.3mm and 4.0mm), Substantially Equivalent on 2016-06-22. Applicant: Laurimed, LLC.
Clearance details
- Applicant
- Laurimed, LLC
- Product code
- Code ERL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redwood City, CA, US
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.