GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY— 510(k) K892523

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K892523 for GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY, Substantially Equivalent on 1989-05-11. Applicant: Gambro, Inc..

Clearance details

Applicant: Gambro, Inc.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1989-04-11
Decision date: 1989-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, US

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Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.