Predicate III Guidewire— 510(k) K142397

Substantially Equivalent

Lake Region Medical

FDA 510(k) clearance K142397 for Predicate III Guidewire, Substantially Equivalent on 2014-09-19. Applicant: Lake Region Medical.

Clearance details

Applicant: Lake Region Medical
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 2014-08-27
Decision date: 2014-09-19
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.