NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE— 510(k) K060034

Substantially Equivalent

Nipro Medical Corporation

FDA 510(k) clearance K060034 for NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE, Substantially Equivalent on 2006-02-28. Applicant: Nipro Medical Corporation.

Clearance details

Applicant: Nipro Medical Corporation
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 2006-01-05
Decision date: 2006-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, KY, US

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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.