SOFTINJECT— 510(k) K991680

Substantially Equivalent

Androsystems Srl

FDA 510(k) clearance K991680 for SOFTINJECT, Substantially Equivalent on 1999-06-03. Applicant: Androsystems Srl.

Clearance details

Applicant: Androsystems Srl
Product code: Code KZH
Advisory panel: General Hospital
Date received: 1999-05-17
Decision date: 1999-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, IT

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.