510(k) K254196 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
| Applicant | Ethicon Endo-Surgery, LLC, Guaynabo PR, US |
| Decision | Substantially Equivalent, Sep 17, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254196
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.