POLYPLEX STIMULATING CATHETER SYSTEM— 510(k) K060186

Substantially Equivalent

Te ME NA Sas

FDA 510(k) clearance K060186 for POLYPLEX STIMULATING CATHETER SYSTEM, Substantially Equivalent on 2006-07-18. Applicant: Te ME NA Sas.

Clearance details

Applicant: Te ME NA Sas
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 2006-01-24
Decision date: 2006-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.