BARD INLAYOPTIMA URETERAL STENT WITH SUTURE— 510(k) K043193

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K043193 for BARD INLAYOPTIMA URETERAL STENT WITH SUTURE, Substantially Equivalent on 2004-12-07. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2004-11-18
Decision date: 2004-12-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Covington, GA, US

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Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.