LAURIMED POLYPVAC MICRODEBRIDER— 510(k) K133133

Substantially Equivalent

Laurimed, LLC

FDA 510(k) clearance K133133 for LAURIMED POLYPVAC MICRODEBRIDER, Substantially Equivalent on 2013-12-23. Applicant: Laurimed, LLC.

Clearance details

Applicant: Laurimed, LLC
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2013-09-30
Decision date: 2013-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.