510(k) Report

Devices descending from K100078

5 later devices reach Modified Straight Fire Laser Fiber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+1K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+1K110685Flexiva TractipBoston Scientific Corp20112—
+1K110686AccutracBoston Scientific Corp20110—
+2K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—