DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES— 510(k) K861153

Substantially Equivalent

Exel Intl.

FDA 510(k) clearance K861153 for DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES, Substantially Equivalent on 1986-04-23. Applicant: Exel Intl..

Clearance details

Applicant: Exel Intl.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1986-03-26
Decision date: 1986-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.