U&U Enteral Syringe— 510(k) K160855

Clearance details

Applicant

U&U Medical Technology Co, Ltd.

Product code

Code PNR

Device class

Class 2

Regulation

21 CFR 876.5980

Advisory panel

Gastroenterology, Urology

Date received

2016-03-28

Decision date

2016-11-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Changzhou, CN

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• K171823 — U&U Indicator tape and strip2018-02-22
• K152808 — U&U Insulin Syringe with/without Safety Retractable Device2016-03-25
• K151151 — U & U Intravascular Administration Set2015-09-24
• K143637 — U&U Sterilization Pouch and Roll2015-09-09

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 →