APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE— 510(k) K971498

Name: FDA 510(k) clearance K971498
Creator: U.S. Food and Drug Administration
Published: 1997-05-05

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K971498 for APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE, Substantially Equivalent on 1997-05-05. Applicant: Applied Medical Resources. Device class: 1.

Clearance details

Applicant: Applied Medical Resources
Product code: Code EZB
Device class: Class 1
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-25
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EZB

product code EZB

Death: 4
Injury: 141
Malfunction: 588
Total: 733

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.