INNOJECT AUTO-INJECTOR— 510(k) K042557

Substantially Equivalent

Innoject, Inc.

FDA 510(k) clearance K042557 for INNOJECT AUTO-INJECTOR, Substantially Equivalent on 2004-11-08. Applicant: Innoject, Inc..

Clearance details

Applicant: Innoject, Inc.
Product code: Code KZH
Advisory panel: General Hospital
Date received: 2004-09-20
Decision date: 2004-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.