PIF — Gastrointestinal Tubes With Enteral Specific Connectors Class II
FDA product code PIF covers "Gastrointestinal Tubes With Enteral Specific Connectors", a Class II medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PIF
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To facilitate enteral specific connections.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254170 | degania silicone | Percutaneous Endoscopic Gastrostomy (PEG) Kit | March 20, 2026 |
| K242917 | hmc premedical | Enteral Drainage System, Enteral Medicine straw | June 18, 2025 |
| K250481 | sky medical, a.s | Extension Feeding Set with ENFit Connectors | April 18, 2025 |
| K240052 | beijing l and z medical technology development co | Disposable Enteral Feeding Sets | July 3, 2024 |
| K233034 | rockfield medical | Mobility+ Enteral Feeding System OTC | April 12, 2024 |
| K230326 | vesco medical | ENFit to ENFit Extension Sets | November 2, 2023 |
| K232046 | xeridiem medical devices, a spectrum plastics group | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT | October 6, 2023 |
| K222773 | anhui tiankang medical technology co | Feeding Tube | August 17, 2023 |
| K223683 | vonco products | EnteraLoc Flow | July 10, 2023 |
| K222678 | rockfield medical | Mobility+ Enteral Feeding System | October 27, 2022 |
| K213258 | cair lgl | Nasogastric Feeding Tubes - ENFit Port - PVC | June 9, 2022 |
| K213174 | cardinalhealth | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | May 19, 2022 |
| K213356 | wilson-cook medical | Entuit PEG, Entuit PEGJ | January 20, 2022 |
| K210854 | kb medical (group) | Enteral Feeding Set | November 16, 2021 |
| K210598 | cair lgl | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | November 2, 2021 |
| K203633 | gbuk group | Enteral Extension Sets | August 19, 2021 |
| K210971 | vonco products | EnteraLoc Flow | August 18, 2021 |
| K201741 | syncro medical innovations | Gabriel 3 Way EnFit Valve | November 5, 2020 |
| K202357 | three circles consulting limited | Nutricare Clear-ISOSAF Nasogastric Feeding Tube | October 1, 2020 |
| K192991 | vesco medical | Vesco Medical Extension Feeding Set | August 3, 2020 |