MANDREL GUIDEWIRES OR M-WIRE— 510(k) K080508

Substantially Equivalent

Lake Region Medical

FDA 510(k) clearance K080508 for MANDREL GUIDEWIRES OR M-WIRE, Substantially Equivalent on 2008-03-21. Applicant: Lake Region Medical.

Clearance details

Applicant: Lake Region Medical
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 2008-02-25
Decision date: 2008-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.