NEXUS INJECTION SITE, MODEL NIS-8— 510(k) K092527

Substantially Equivalent

Nexus Medical, LLC

FDA 510(k) clearance K092527 for NEXUS INJECTION SITE, MODEL NIS-8, Substantially Equivalent on 2010-02-04. Applicant: Nexus Medical, LLC.

Clearance details

Applicant: Nexus Medical, LLC
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2009-08-18
Decision date: 2010-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.