NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER— 510(k) K110285

Substantially Equivalent

Nephros, Inc.

FDA 510(k) clearance K110285 for NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER, Substantially Equivalent on 2011-07-14. Applicant: Nephros, Inc..

Clearance details

Applicant: Nephros, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2011-01-31
Decision date: 2011-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: River Edge, NJ, US

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Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

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.