510(k) K241039 ยท KNT Tubes, Gastrointestinal (And Accessories)
ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
| Applicant | Reshape Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, May 16, 2024 |
| Received | Apr 16, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241039
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.