510(k) K260255 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
| Applicant | Aventix Medical, Inc., Laguna Hills CA, US |
| Decision | Substantially Equivalent, Mar 27, 2026 |
| Received | Jan 28, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260255
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.