FDA Product Code
FDA Product Code PIF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5980
510(k) Clearances — 52 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260110 | danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH | 2026-09-10 | Traditional | PDF ↗ |
| 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); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | Maquet Critical Care AB | 2026-08-26 | Traditional | PDF ↗ |
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone , Ltd. | 2026-03-20 | Traditional | PDF ↗ |
| K242917 | Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. | 2025-06-18 | Traditional | PDF ↗ |
| K250481 | Extension Feeding Set with ENFit Connectors | SKY Medical, a.s. | 2025-04-18 | Traditional | PDF ↗ |
| K240052 | Disposable Enteral Feeding Sets | Beijing L&Z Medical Technology Development Co., Ltd. | 2024-07-03 | Traditional | PDF ↗ |
| K233034 | Mobility+ Enteral Feeding System OTC | Rockfield Medical | 2024-04-12 | Traditional | PDF ↗ |
| K230326 | ENFit to ENFit Extension Sets | Vesco Medical | 2023-11-02 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 | Traditional | PDF ↗ |
| K223683 | EnteraLoc Flow | Vonco Products | 2023-07-10 | Traditional | PDF ↗ |
| K222678 | Mobility+ Enteral Feeding System | Rockfield Medical | 2022-10-27 | Traditional | PDF ↗ |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | 2022-06-09 | Traditional | PDF ↗ |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2022-05-19 | Traditional | PDF ↗ |
| K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2022-01-20 | Special | PDF ↗ |
| K210854 | Enteral Feeding Set | Kb Medical (Group), Inc. | 2021-11-16 | Traditional | PDF ↗ |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair Lgl | 2021-11-02 | Traditional | PDF ↗ |
| K203633 | Enteral Extension Sets | GBUK Group, Ltd. | 2021-08-19 | Traditional | PDF ↗ |
| K210971 | EnteraLoc Flow | Vonco Products | 2021-08-18 | Traditional | PDF ↗ |
| K201741 | Gabriel 3 Way EnFit Valve | Syncro Medical Innovations, Inc. | 2020-11-05 | Traditional | PDF ↗ |
| K202357 | Nutricare Clear-ISOSAF Nasogastric Feeding Tube | Three Circles Consulting Limited | 2020-10-01 | Traditional | PDF ↗ |
| K192991 | Vesco Medical Extension Feeding Set | Vesco Medical, LLC | 2020-08-03 | Traditional | PDF ↗ |
| K200082 | BD Univia RightFit Enteral Extension Sets and Transitional Adapters | Mps Medical, Inc. | 2020-07-30 | Traditional | PDF ↗ |
| K191759 | Medline Quick Switch Valve with ENFit Connector | Medline Industries, Inc. | 2019-12-04 | Traditional | PDF ↗ |
| K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | Syncro Medical Innovations, Inc. | 2019-11-15 | Traditional | PDF ↗ |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2019-11-07 | Traditional | PDF ↗ |
| K190414 | Moss Gastrostomy Tube, Moss Nasal Tube Mark IV | Moss Tubes, Inc. | 2019-06-14 | Special | PDF ↗ |
| K190310 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | 2019-05-31 | Traditional | PDF ↗ |
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | Cedic S.R.L. | 2019-04-25 | Traditional | PDF ↗ |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus Adapter | Cedic S.R.L. | 2019-04-09 | Traditional | PDF ↗ |
| 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, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018-10-18 | Traditional | PDF ↗ |
| K181276 | CONOD Enteral Feeding Sets | Conod Medical Co., Limited | 2018-07-12 | Traditional | PDF ↗ |
| K170162 | Vesco Medical Nasoenteric Feeding Tubes | Vesco Medical, LLC | 2017-09-26 | Traditional | PDF ↗ |
| K170555 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | 2017-08-17 | Traditional | PDF ↗ |
| K171347 | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | Xeridiem Medical Devices | 2017-06-06 | Special | PDF ↗ |
| K163586 | Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector | Trovrx, Inc. Dba Trovita Health Science | 2017-03-17 | Traditional | PDF ↗ |
| K153688 | Edi Catheter ENFit | Maquet Critical Care AB | 2017-03-02 | Traditional | PDF ↗ |
| K160642 | Medline ENFit Syringe | Medline Industries, Inc. | 2016-11-29 | Traditional | PDF ↗ |
| K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector | Boston Scientific Corporation | 2016-06-17 | Traditional | PDF ↗ |
| K151503 | NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE | Gbuk Enteral Limited | 2016-04-05 | Traditional | PDF ↗ |
| K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional Port | Covidien | 2015-10-08 | Traditional | PDF ↗ |
| K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector | Covidien | 2015-07-13 | Traditional | PDF ↗ |
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector | Boston Scientific Corp | 2015-05-29 | Traditional | PDF ↗ |
| K150286 | Medline Enteral Feeding Sets | Medline Industries, Inc. | 2015-04-27 | Traditional | PDF ↗ |
| K143018 | Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors | Covidien | 2015-04-02 | Traditional | PDF ↗ |
| K142989 | Mini ONE Enteral Extension Set | Applied Medical Technology, Inc. | 2015-01-29 | Traditional | PDF ↗ |
| K142075 | BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE | Xeridiem (Formerly Mri) | 2015-01-08 | Traditional | PDF ↗ |
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set | Zevex, Inc. | 2015-01-08 | Traditional | PDF ↗ |
| K142297 | Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set | Xeridiem (Formerly Mri) | 2015-01-08 | Traditional | PDF ↗ |
| K142012 | FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS | Corpak Medsystems | 2014-11-20 | Traditional | PDF ↗ |
| K141753 | AQUARIUS NASAL FEEDING TUBE | Degania Silicone , Ltd. | 2014-10-16 | Traditional | PDF ↗ |
| K140947 | COMPAT ENTERAL DELIVERY PUMP SETS | Nestle Healthcare Nutrition, Inc. | 2014-09-04 | Traditional | PDF ↗ |
Product code PIF · Class II · Gastroenterology, Urology. Data: openFDA.