510(k) K222085 ยท KNT Tubes, Gastrointestinal (And Accessories)
Standard Tapered Bougie, 38 Fr.
| Applicant | Standard Bariatrics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Oct 31, 2022 |
| Received | Jul 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222085
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.