BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE— 510(k) K983498

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K983498 for BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE, Substantially Equivalent on 1998-12-15. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1998-10-05
Decision date: 1998-12-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.