510(k) K251759 ยท GEX Powered Laser Surgical Instrument
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
| Applicant | Boston Scientific Corporation, Marlborough MA, US |
| Decision | Substantially Equivalent, Jul 9, 2025 |
| Received | Jun 9, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251759
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.