U&U Enteral Syringe
FDA 510(k) K160855 · U&U Medical Technology Co, Ltd.
510(k) numberK160855
Submission
- Device name
- U&U Enteral Syringe
- Applicant
- U&U Medical Technology Co, Ltd.
Changzhou, CN - Received
- March 28, 2016
- Decision date
- November 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNR – Enteral Syringes With Enteral Specific Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252483 | Enteral Syringe (20ml, 60ml)PNR · Traditional | Chirana T.Injecta,A.S. | 07/01/2026SE |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…PNR · Traditional | CMT Health PTE., Ltd. | 04/08/2026SE |
| K251585 | Profoject Enteral Feeding SyringePNR · Traditional | CMT Health PTE., Ltd. | 07/18/2025SE |
| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with…PNR · Special | Cardinalhealth | 12/19/2024SE |
| K231300 | Nutricair Enteral Syringe with ENFitPNR · Traditional | Cair Lgl | 10/06/2023SE |
| K222772 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/17/2023SE |
| K211661 | ENFit enteral syringes (NUTRIFIT)PNR · Traditional | Pentaferte Italia S.R.L. | 02/28/2022SE |
| K211593 | Enteral Pump SyringePNR · Traditional | Jiangsu Caina Medical Co.,Ltd | 09/30/2021SE |
| K203613 | ENFit Reusable Enteral SyringePNR · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 08/27/2021SE |
| K211025 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | Ningbo Tianyi Medical Appliance Co., Ltd. | 06/30/2021SE |
More from Ningbo Tianyi Medical Appliance Co., Ltd.
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|---|---|---|
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| K152808 | U&U Insulin Syringe with/without Safety Retractable DeviceMEG · Traditional | 03/25/2016SE |
| K151151 | U & U Intravascular Administration SetFPA · Traditional | 09/24/2015SE |
| K143637 | U&U Sterilization Pouch and RollFRG · Traditional | 09/09/2015SE |
| K143629 | U&U Bowie-Dick Test PackJOJ · Traditional | 05/19/2015SE |
| K132553 | U&U Sterile Piston Syringe Without NeedleFMF · Traditional | 02/27/2014SE |
| K123162 | U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/RollFRG · Traditional | 02/26/2014SE |
| K132552 | U&U Sterile Hypodermic NeedleFMI · Traditional | 11/13/2013SE |
Questions and answers
When was U&U Enteral Syringe cleared by the FDA?
U&U Enteral Syringe (K160855) received a 510(k) decision of Substantially Equivalent on November 22, 2016, 239 days after the submission was received.
What is the product code of K160855?
The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.