SPLIT CATH RG— 510(k) K130889

Name: FDA 510(k) clearance K130889
Creator: U.S. Food and Drug Administration
Published: 2014-04-28

Unknown

Medcomp

FDA 510(k) clearance K130889 for SPLIT CATH RG, Unknown on 2014-04-28. Applicant: Medcomp. Device class: 2.

Clearance details

Applicant: Medcomp
Product code: Code MSD
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-29
Decision date: 2014-04-28
Decision: Unknown
Clearance type: Traditional
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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.