510(k) K231405 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode
| Applicant | Jiangsu Rong FU Kang Medical Instruments Co., Ltd., Jiangyin, CN |
| Decision | Substantially Equivalent, Jan 18, 2024 |
| Received | May 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231405
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.