BARD URETEROSCOPIC DEVICE— 510(k) K883110

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K883110 for BARD URETEROSCOPIC DEVICE, Substantially Equivalent on 1988-10-21. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 1988-07-25
Decision date: 1988-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

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Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.