Nasogastric Feeding Tubes - ENFit Port - PVC
FDA 510(k) K213258 · Cair Lgl
510(k) numberK213258
Submission
- Device name
- Nasogastric Feeding Tubes - ENFit Port - PVC
- Applicant
- Cair Lgl
Lissieu, FR - Received
- September 30, 2021
- Decision date
- June 9, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PIF – Gastrointestinal Tubes With Enteral Specific Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
To facilitate enteral specific connections.
Other 510(k)s with product code PIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260110 | danumed Extension Set for Gastrostomy ButtonPIF · Traditional | Danumed Medizintechnik GmbH | 09/10/2026SE |
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…PIF · Traditional | Maquet Critical Care AB | 08/26/2026SE |
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) KitPIF · Traditional | Degania Silicone , Ltd. | 03/20/2026SE |
| K242917 | Enteral Drainage System, Enteral Medicine strawPIF · Traditional | HMC Premedical S.p.A. | 06/18/2025SE |
| K250481 | Extension Feeding Set with ENFit ConnectorsPIF · Traditional | SKY Medical, a.s. | 04/18/2025SE |
| K240052 | Disposable Enteral Feeding SetsPIF · Traditional | Beijing L&Z Medical Technology Development Co.… | 07/03/2024SE |
| K233034 | Mobility+ Enteral Feeding System OTCPIF · Traditional | Rockfield Medical | 04/12/2024SE |
| K230326 | ENFit to ENFit Extension SetsPIF · Traditional | Vesco Medical | 11/02/2023SE |
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…PIF · Traditional | Xeridiem Medical Devices, A Spectrum Plastics… | 10/06/2023SE |
| K222773 | Feeding TubePIF · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/17/2023SE |
More from Anhui Tiankang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connectorPIO · Traditional | 01/22/2024SE |
| K231300 | Nutricair Enteral Syringe with ENFitPNR · Traditional | 10/06/2023SE |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit PortPIF · Traditional | 11/02/2021SE |
| K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000)FPA · Traditional | 09/01/2017SE |
| K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)FPA · Traditional | 08/15/2017SE |
| K171132 | Carefusion NeutraClear Needle-free connectorFPA · Special | 07/31/2017SE |
| K133073 | Cair Drive, NeutraclearFPA · Traditional | 03/20/2014SE |
Questions and answers
When was Nasogastric Feeding Tubes - ENFit Port - PVC cleared by the FDA?
Nasogastric Feeding Tubes - ENFit Port - PVC (K213258) received a 510(k) decision of Substantially Equivalent on June 9, 2022, 252 days after the submission was received.
What is the product code of K213258?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.