ENFit Disposable Enteral Syringe
FDA 510(k) K203410 · Shantou Wealy Medical Instrument Co.,Ltd
510(k) numberK203410
Submission
- Device name
- ENFit Disposable Enteral Syringe
- Applicant
- Shantou Wealy Medical Instrument Co.,Ltd
Shantou, CN - Received
- November 19, 2020
- Decision date
- June 28, 2021
- 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 |
|---|---|---|
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional | 11/23/2022SE |
| K210216 | Disposable Automatically Retractable Insulin Safety SyringeMEG · Traditional | 03/04/2022SE |
| K203613 | ENFit Reusable Enteral SyringePNR · Traditional | 08/27/2021SE |
| K141640 | Automatically Retractable Safety Syringes with Fixed NeedleMEG · Traditional | 11/19/2014SE |
| K113587 | Automatically Retractable Safety Syringe (with Fixed Needle)MEG · Traditional | 02/24/2012SE |
Questions and answers
When was ENFit Disposable Enteral Syringe cleared by the FDA?
ENFit Disposable Enteral Syringe (K203410) received a 510(k) decision of Substantially Equivalent on June 28, 2021, 221 days after the submission was received.
What is the product code of K203410?
The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.