Product areas
FDA product code distribution
FDA product code distribution
4 total
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K260100 | MOSES Raydar™ | GEX | Class 2 | 2026-05-18 |
| K252529 | Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) | GEX | Class 2 | 2025-10-30 |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers | GEX | Class 2 | 2025-07-09 |
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber | GEX | Class 2 | 2021-04-28 |
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
1 submission cite Boston Scientific Corporation as a predicate