NIVATOPIC PLUS— 510(k) K132329

Substantially Equivalent

Nivagen Pharmaceuticals, Inc.

FDA 510(k) clearance K132329 for NIVATOPIC PLUS, Substantially Equivalent on 2013-12-20. Applicant: Nivagen Pharmaceuticals, Inc..

Clearance details

Applicant: Nivagen Pharmaceuticals, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2013-07-26
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Wiley, SC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.