PIF
- Product code
- PIF
- Device name
- Gastrointestinal Tubes With Enteral Specific Connectors
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 51 (all years; only the last 3 years are listed here)
FDA classification definition
To facilitate enteral specific connections.
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253715 | 2026-08-26 | Maquet Critical Care AB | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter… | |
| K254170 | 2026-03-20 | Degania Silicone , Ltd. | Percutaneous Endoscopic Gastrostomy (PEG) Kit | |
| K242917 | 2025-06-18 | HMC Premedical S.p.A. | Enteral Drainage System, Enteral Medicine straw | FDA |
| K250481 | 2025-04-18 | SKY Medical, a.s. | Extension Feeding Set with ENFit Connectors | |
| K240052 | 2024-07-03 | Beijing L&Z Medical Technology Develop… | Disposable Enteral Feeding Sets | |
| K233034 | 2024-04-12 | Rockfield Medical | Mobility+ Enteral Feeding System OTC | |
| K230326 | 2023-11-02 | Vesco Medical | ENFit to ENFit Extension Sets | |
| K232046 | 2023-10-06 | Xeridiem Medical Devices, A Spectrum P… | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaro… |
Official FDA classification page: PIF
Classification and pathway per current FDA publications. Data from openFDA (CC0).