U&U STERILE PISTON SYRINGE WITHOUT NEEDLE— 510(k) K132553

Substantially Equivalent

U&U Medical Technology Co, Ltd.

FDA 510(k) clearance K132553 for U&U STERILE PISTON SYRINGE WITHOUT NEEDLE, Substantially Equivalent on 2014-02-27. Applicant: U&U Medical Technology Co, Ltd..

Clearance details

Applicant: U&U Medical Technology Co, Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2013-08-14
Decision date: 2014-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, Jiangsu, CN

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.