PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS— 510(k) K854909

Substantially Equivalent

Angiomed U.S., Inc.

FDA 510(k) clearance K854909 for PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS, Substantially Equivalent on 1986-01-24. Applicant: Angiomed U.S., Inc..

Clearance details

Applicant: Angiomed U.S., Inc.
Product code: Code GBO
Advisory panel: General, Plastic Surgery
Date received: 1985-12-09
Decision date: 1986-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

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Adverse events under product code GBO

product code GBO

Death: 8
Injury: 236
Total: 244

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.