ENFit enteral syringes (NUTRIFIT)
FDA 510(k) K211661 · Pentaferte Italia S.R.L.
510(k) numberK211661
Submission
- Device name
- ENFit enteral syringes (NUTRIFIT)
- Applicant
- Pentaferte Italia S.R.L.
Campli, IT - Received
- June 1, 2021
- Decision date
- February 28, 2022
- 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 |
| 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 |
| K203410 | ENFit Disposable Enteral SyringePNR · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 06/28/2021SE |
More from Shantou Wealy Medical Instrument Co.,Ltd
Questions and answers
When was ENFit enteral syringes (NUTRIFIT) cleared by the FDA?
ENFit enteral syringes (NUTRIFIT) (K211661) received a 510(k) decision of Substantially Equivalent on February 28, 2022, 272 days after the submission was received.
What is the product code of K211661?
The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.