Product code PIF
- Device name
- Gastrointestinal Tubes With Enteral Specific Connectors
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To facilitate enteral specific connections.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260110 | danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH | 2026-09-10 |
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); ... | Maquet Critical Care AB | 2026-08-26 |
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone , Ltd. | 2026-03-20 |
| K242917 | Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. | 2025-06-18 |
| K250481 | Extension Feeding Set with ENFit™ Connectors | SKY Medical, a.s. | 2025-04-18 |
| K240052 | Disposable Enteral Feeding Sets | Beijing L&Z Medical Technology Development Co., Ltd. | 2024-07-03 |
| K233034 | Mobility+ Enteral Feeding System OTC | Rockfield Medical | 2024-04-12 |
| K230326 | ENFit to ENFit Extension Sets | Vesco Medical | 2023-11-02 |
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2023-10-06 |
| K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 |
| K223683 | EnteraLoc Flow | Vonco Products | 2023-07-10 |
| K222678 | Mobility+ Enteral Feeding System | Rockfield Medical | 2022-10-27 |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | 2022-06-09 |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2022-05-19 |
| K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2022-01-20 |
| K210854 | Enteral Feeding Set | Kb Medical (Group), Inc. | 2021-11-16 |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair Lgl | 2021-11-02 |
| K203633 | Enteral Extension Sets | GBUK Group, Ltd. | 2021-08-19 |
| K210971 | EnteraLoc Flow | Vonco Products | 2021-08-18 |
| K201741 | Gabriel 3 Way EnFit Valve | Syncro Medical Innovations, Inc. | 2020-11-05 |
| K202357 | Nutricare Clear-ISOSAF Nasogastric Feeding Tube | Three Circles Consulting Limited | 2020-10-01 |
| K192991 | Vesco Medical Extension Feeding Set | Vesco Medical, LLC | 2020-08-03 |
| K200082 | BD Univia RightFit Enteral Extension Sets and Transitional Adapters | Mps Medical, Inc. | 2020-07-30 |
| K191759 | Medline Quick Switch Valve with ENFit Connector | Medline Industries, Inc. | 2019-12-04 |
| K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | Syncro Medical Innovations, Inc. | 2019-11-15 |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2019-11-07 |
| K190414 | Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV | Moss Tubes, Inc. | 2019-06-14 |
| K190310 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | 2019-05-31 |
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | Cedic S.R.L. | 2019-04-25 |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus Adapter | Cedic S.R.L. | 2019-04-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060590884393 | Enteral | GBUK GROUP LIMITED | 2024-01-24 |
| 05060590884423 | Enteral | GBUK GROUP LIMITED | 2024-01-23 |
| 05060590884669 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590884638 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590884607 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590884577 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590884553 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590884515 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590884485 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590884454 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590882665 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590882788 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590882757 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590882726 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590882696 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590882634 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590882603 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590882573 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590882542 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844632 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844571 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844519 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844458 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844427 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844366 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844304 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844243 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844113 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460844083 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 20884521706177 | Kangaroo | Cardinal Health, Inc. | 2017-04-20 |