DARWIN HYPODERMIC SAFETY SYSTEM (DHSS)— 510(k) K952837

Substantially Equivalent

Emk Enterprises, LLC

FDA 510(k) clearance K952837 for DARWIN HYPODERMIC SAFETY SYSTEM (DHSS), Substantially Equivalent on 1996-01-30. Applicant: Emk Enterprises, LLC.

Clearance details

Applicant: Emk Enterprises, LLC
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1995-06-19
Decision date: 1996-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.