510(k) K212786 ยท HIF Insufflator, Laparoscopic
LevaLap Laparoscopic Access Device
| Applicant | Core Access Surgical Technologies, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, Feb 23, 2022 |
| Received | Sep 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212786
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.