ENDOCARE PERCUTANEOUS ACCESS SET— 510(k) K010339

Name: FDA 510(k) clearance K010339
Creator: U.S. Food and Drug Administration
Published: 2001-03-07

Substantially Equivalent

Endocare, Inc.

FDA 510(k) clearance K010339 for ENDOCARE PERCUTANEOUS ACCESS SET, Substantially Equivalent on 2001-03-07. Applicant: Endocare, Inc.. Device class: 2.

Clearance details

Applicant: Endocare, Inc.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2001-02-05
Decision date: 2001-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.