510(k) K232046 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
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 |
| Decision | Substantially Equivalent, Oct 6, 2023 |
| Received | Jul 10, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232046
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.