Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
FDA 510(k) K143018 · Covidien
510(k) numberK143018
Submission
- Device name
- Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
- Applicant
- Covidien
Mansfield, MA, US - Received
- October 20, 2014
- Decision date
- April 2, 2015
- 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.
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| K250481 | Extension Feeding Set with ENFit ConnectorsPIF · Traditional | SKY Medical, a.s. | 04/18/2025SE |
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| 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 |
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Questions and answers
When was Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors cleared by the FDA?
Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors (K143018) received a 510(k) decision of Substantially Equivalent on April 2, 2015, 164 days after the submission was received.
What is the product code of K143018?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.