U&U Enteral Syringe— 510(k) K160855

Substantially Equivalent

U&U Medical Technology Co, Ltd.

FDA 510(k) clearance K160855 for U&U Enteral Syringe, Substantially Equivalent on 2016-11-22. Applicant: U&U Medical Technology Co, Ltd..

Clearance details

Applicant: U&U Medical Technology Co, Ltd.
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2016-03-28
Decision date: 2016-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code PNR

product code PNR

Other: 6
Total: 6

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.