RENAL SYSTEMS PERITONEAL ACCESS SYSTEM— 510(k) K844108

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K844108 for RENAL SYSTEMS PERITONEAL ACCESS SYSTEM, Substantially Equivalent on 1985-01-07. Applicant: Renal Systems, Inc..

Clearance details

Applicant: Renal Systems, Inc.
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 1984-10-23
Decision date: 1985-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.