Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
FDA 510(k) K232046 · Xeridiem Medical Devices, A Spectrum Plastics Group Company
510(k) numberK232046
Submission
- Device name
- Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
- Applicant
- Xeridiem Medical Devices, A Spectrum Plastics Group Company
Tucson, AZ, US - Received
- July 10, 2023
- Decision date
- October 6, 2023
- 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 |
| K222773 | Feeding TubePIF · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/17/2023SE |
| K223683 | EnteraLoc FlowPIF · Traditional | Vonco Products | 07/10/2023SE |
More from Vonco Products
| 510(k) | Device | Decision |
|---|---|---|
| K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…PIF · Traditional | 10/18/2018SESK |
Questions and answers
When was Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection cleared by the FDA?
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection (K232046) received a 510(k) decision of Substantially Equivalent on October 6, 2023, 88 days after the submission was received.
What is the product code of K232046?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.