Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection— 510(k) K232046
Substantially EquivalentXeridiem Medical Devices, A Spectrum Plastics Group Company
FDA 510(k) clearance K232046 for Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection, Substantially Equivalent on 2023-10-06. Applicant: Xeridiem Medical Devices, A Spectrum Plastics Group Company. Device class: 2.
Clearance details
- Applicant
- Xeridiem Medical Devices, A Spectrum Plastics Group Company
- Product code
- Code PIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code PIF
view allMore clearances from Xeridiem Medical Devices, A Spectrum Plastics Group Company
view allAdverse events under product code PIF
product code PIF- Death
- 13
- Injury
- 122
- Other
- 1
- Total
- 136
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.