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 |
|---|---|---|---|
| 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 |
| K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection,... | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018-10-18 |
| K181276 | CONOD Enteral Feeding Sets | Conod Medical Co., Limited | 2018-07-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056093721058 | Compat Enteral Feeding tube 16Fr 90cm | CEDIC SRL | 2019-12-13 |
| 08056093721034 | Compat Enteral Feeding tube 14Fr 120cm with stylet | CEDIC SRL | 2019-12-13 |
| 08056093721010 | Compat Enteral Feeding tube 14Fr 120cm | CEDIC SRL | 2019-12-13 |
| 08056093720839 | Compat Junior Enteral Feeding tube 8Fr 76cm with stylet | CEDIC SRL | 2019-12-13 |
| 08056093720853 | Compat Enteral Feeding tube 8Fr 120cm | CEDIC SRL | 2019-12-13 |
| 08056093720877 | Compat Enteral Feeding tube 8Fr 120cm with stylet | CEDIC SRL | 2019-12-13 |
| 08056093720891 | Compat Enteral Feeding tube 10Fr 120cm | CEDIC SRL | 2019-12-13 |
| 08056093720914 | Compat Enteral Feeding tube 10Fr 120cm with stylet | CEDIC SRL | 2019-12-13 |
| 08056093720938 | Compat Enteral Feeding tube 12Fr 90cm | CEDIC SRL | 2019-12-13 |
| 08056093720952 | Compat Enteral Feeding tube 12Fr 120cm | CEDIC SRL | 2019-12-13 |
| 08056093720976 | Compat Enteral Feeding tube 12Fr 120cm with stylet | CEDIC SRL | 2019-12-13 |
| 08056093720990 | Compat Enteral Feeding tube 14Fr 90cm | CEDIC SRL | 2019-12-13 |
| 08056093720778 | Compat Junior Enteral Feeding tube 6Fr 90cm | CEDIC SRL | 2019-12-12 |
| 08056093720792 | Compat Junior Enteral Feeding tube 6Fr 90cm with stylet | CEDIC SRL | 2019-12-12 |
| 08056093720754 | Compat Junior Enteral Feeding tube 5Fr 50cm | CEDIC SRL | 2019-12-12 |
| 08056093720815 | Compat Junior Enteral Feeding tube 8Fr 50cm | CEDIC SRL | 2019-12-12 |
| 08714729863397 | EndoVive Button Decompression Tube | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863533 | EndoVive Button Decompression Tube | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863519 | EndoVive Button Decompression Tube | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863496 | EndoVive Button Decompression Tube | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863472 | EndoVive Button Decompression Tube | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863458 | EndoVive Button Decompression Tube | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863434 | EndoVive Button Decompression Tube | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863410 | EndoVive Button Decompression Tube | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863366 | EndoVive Button Bolus Feeding Set | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863342 | EndoVive Button Bolus Feeding Set | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863311 | EndoVive Button Right Angle Feeding Set | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863298 | EndoVive Button Right Angle Feeding Set | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863274 | EndoVive Button Right Angle Feeding Set | BOSTON SCIENTIFIC CORPORATION | 2016-10-15 |
| 08714729863557 | EndoVive Y-Port Feeding Adapter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |