Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
FDA 510(k) K150084 · Covidien
510(k) numberK150084
Submission
- Device name
- Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
- Applicant
- Covidien
Mansfield, MA, US - Received
- January 15, 2015
- Decision date
- July 13, 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.
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 |
|---|---|---|
| K260907 | BIS Advance pEEG ModuleOLW · Traditional | 08/13/2026SE |
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0…GAG · Traditional | 07/01/2026SE |
| K253984 | Instrument Exit Point on Touch Surgery AideSFE · Traditional | 06/04/2026SE |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN)CCK · Traditional | 05/01/2026SE |
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with…JOH · Traditional | 12/29/2025SE |
| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043…BZT · Traditional | 12/29/2025SE |
| K250725 | Hugo RAS SystemSCV · Traditional | 12/03/2025SE |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal…BTR · Traditional | 10/06/2025SE |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley…BTR · Traditional | 09/25/2025SE |
| K241486 | Sofsilk Coated Braided Silk SutureGAP · Traditional | 12/03/2024SE |
Questions and answers
When was Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector cleared by the FDA?
Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector (K150084) received a 510(k) decision of Substantially Equivalent on July 13, 2015, 179 days after the submission was received.
What is the product code of K150084?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.