U&U Enteral Syringe
K-Number: K160855 · 2016-11-22
ApplicantU&U Medical Technology Co, Ltd.
Decision Date2016-11-22
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
U&U Enteral Syringe is a medical device manufactured by U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-11-22 under approval number K160855. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the U&U Enteral Syringe?
U&U Enteral Syringe is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by U&U Medical Technology Co, Ltd.. The 510(k) number is K160855.
When was U&U Enteral Syringe approved by the FDA?
U&U Enteral Syringe received FDA 510(k) clearance on 2016-11-22, under approval number K160855.
What company makes U&U Enteral Syringe?
U&U Enteral Syringe is manufactured by U&U Medical Technology Co, Ltd..
What is the FDA product code for U&U Enteral Syringe?
The FDA product code for U&U Enteral Syringe is PNR.
Other Devices by U&U Medical Technology Co, Ltd.
Related Devices (Code: PNR)
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K161045MonojectCovidien
K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)Neomed, Inc.
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K170371DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip SyringeIntervene Group Limited
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.