510(k) K221898 ยท KNT Tubes, Gastrointestinal (And Accessories)
Gastrointestinal Boundary Identifier (GIBI HD)
| Applicant | Reshape Lifesciences, San Clemente CA, US |
| Decision | Substantially Equivalent, Jul 28, 2022 |
| Received | Jun 30, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221898
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.