510(k) K260287 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SP Electrocautery Device (SP20)
| Applicant | Single Pass, Inc., Lake Forest CA, US |
| Decision | Substantially Equivalent, Feb 24, 2026 |
| Received | Jan 29, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260287
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.