R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE— 510(k) K852615

Substantially Equivalent

Medical Hospital Equipment

FDA 510(k) clearance K852615 for R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE, Substantially Equivalent on 1986-03-21. Applicant: Medical Hospital Equipment.

Clearance details

Applicant: Medical Hospital Equipment
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1985-06-12
Decision date: 1986-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chula Vista, CA, 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.