K232046
- 510(k) number
- K232046
- 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 AZ · US
- Product code
- PIF — Gastrointestinal Tubes With Enteral Specific Connect
- Decision date
- 2023-10-06
- Date received
- 2023-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232046.pdf
Official FDA record: K232046
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.