AMSure® Enteral Feeding Syringe with ENFit Tip
FDA 510(k) K171857 · Amsino International, Inc.
510(k) numberK171857
Submission
- Device name
- AMSure® Enteral Feeding Syringe with ENFit Tip
- Applicant
- Amsino International, Inc.
Pomona, CA, US - Received
- June 21, 2017
- Decision date
- March 30, 2018
- 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.
Other 510(k)s with product code PNR
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | 05/04/2026SE |
| K220230 | AMSure Enteral Feeding PumpLZH · Traditional | 11/10/2022SE |
| K220267 | AMSafe NeuFlo Needleless ConnectorFPA · Traditional | 10/07/2022SE |
| K213522 | AMSafe Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 03/22/2022SE |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding SetLZH · Traditional | 09/25/2020SE |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 07/12/2019SE |
| K181445 | AMSure Hydrophilic Intermittent CatheterEZD · Traditional | 10/01/2018SE |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound FlushFRO · Traditional | 09/07/2018SE |
| K173665 | AMSafe Sure-Lok Needle-Free ConnectorFPA · Traditional | 09/05/2018SE |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterEZL · Traditional | 09/04/2018SE |
Questions and answers
When was AMSure® Enteral Feeding Syringe with ENFit Tip cleared by the FDA?
AMSure® Enteral Feeding Syringe with ENFit Tip (K171857) received a 510(k) decision of Substantially Equivalent on March 30, 2018, 282 days after the submission was received.
What is the product code of K171857?
The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.