Clearance Summary
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection received FDA 510(k) clearance under submission number K232046, sponsored by Xeridiem Medical Devices, A Spectrum Plastics Group Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-10-06.
- Submission: K232046
- Applicant / Sponsor: Xeridiem Medical Devices, A Spectrum Plastics Group Company
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2023-10-06
Classification & Regulation
This clearance is catalogued under FDA product code PIF and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.