510(k) K260397 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
| Applicant | Hironic Co., Ltd., Yongin-Si, KR |
| Decision | Substantially Equivalent, Apr 6, 2026 |
| Received | Feb 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260397
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.