U&U Insulin Syringe with/without Safety Retractable Device— 510(k) K152808

Substantially Equivalent

U&U Medical Technology Co, Ltd.

FDA 510(k) clearance K152808 for U&U Insulin Syringe with/without Safety Retractable Device, Substantially Equivalent on 2016-03-25. Applicant: U&U Medical Technology Co, Ltd..

Clearance details

Applicant: U&U Medical Technology Co, Ltd.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2015-09-28
Decision date: 2016-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.