510(k) K161141
- Device
- ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
- Applicant
- PENTAFERTE ITALIA S.R.L.
- 510(k) number
- K161141
- Product code
- PNR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-22
- Date received
- 2016-04-22
- Regulation
- 876.5980
- Classification name
- Enteral Syringes With Enteral Specific Connectors
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROSA DI GIOIA
- Address
- Loc. Nocella Sp 262 Campli IT I-64012 I-64012
FDA Registration Numbers#
- 3006795797
- 3006271008
- 3004099493
- 1423537
- 3005202235
- 3017509841
- 1017768
- 3005515211
- 3005669815
- 3007590959
- 2029275
- 3009742443
- 3011270181
- 1530671
- 3035455509
- 3008311916
- 3000209995
- 3008432385
- 3038294399
- 1423662
- 3014456066
- 8020785
- 1921846
- 3005674464
- 3004756837
- 3014570560
- 3013298431
- 1419937
- 3010331226
- 3014656668
- 3025432964
- 3012039263
- 1061927
- 3023228837
- 1217831
- 3027977504
- 3010131137
- 3014662855
- 3012421607
- 2080225
- 3013557562
- 9612030
- 3005934752
- 3005670221
- 3007441619
- 3042370483
- 3036722184
- 2025917
- 1915484
Source Documents#
Other 510(k) Records For Product Code PNR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | CMT Health PTE., Ltd. | 2026-04-08 |
| K251585 | Profoject™ Enteral Feeding Syringe | CMT Health PTE., Ltd. | 2025-07-18 |
| K243652 | Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) | Cardinalhealth | 2024-12-19 |
| K231300 | Nutricair Enteral Syringe with ENFit | Cair Lgl | 2023-10-06 |
| K222772 | Oral/Enteral Syringe with ENFit connector | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 |
| K211661 | ENFit enteral syringes (NUTRIFIT) | Pentaferte Italia S.R.L. | 2022-02-28 |
| K211593 | Enteral Pump Syringe | Jiangsu Caina Medical Co.,Ltd | 2021-09-30 |
| K203613 | ENFit Reusable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2021-08-27 |
| K211025 | Oral/Enteral Syringe with ENFit connector | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-06-30 |
| K203410 | ENFit Disposable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2021-06-28 |
| K210621 | Oral/Enteral Syringe | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-04-28 |
| K202285 | Medline ENfit OTC Feeding Syringe | Medline Industries, Inc. | 2020-10-09 |
| K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | Jiangsu Shenli Medical Production Co., Ltd. | 2020-09-28 |
| K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | Shinva Ande Healthcare Apparatus Co., Ltd. | 2020-09-12 |
| K190502 | ENFit Oral / Enteral Syringe | Jiangsu Caina Medical Co.,Ltd | 2019-08-06 |
Legacy Summary#
summary
FDA Review#
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