OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016— 510(k) K041983

Name: FDA 510(k) clearance K041983
Creator: U.S. Food and Drug Administration
Published: 2004-11-17

Substantially Equivalent

Opticon Medical

FDA 510(k) clearance K041983 for OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016, Substantially Equivalent on 2004-11-17. Applicant: Opticon Medical. Device class: 2.

Clearance details

Applicant: Opticon Medical
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2004-07-23
Decision date: 2004-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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 →

Recalls naming K041983

K-number listed on FDA's recall record

Z-2831-2016 — Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.Class II·Terminated·C.R. Bard, Inc.·20160711

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041983.

Data sourced from openFDA. This site is unofficial and independent of the FDA.