Product areas
FDA product code distribution
Boston Scientific Corporation
Country / region:United States (US)
510(k) submissions
4
Filtered: GEX
Latest clearance
2026-05-18
Product codes
1
GEX
510(k) submissions
4 total · filtered by GEX
| 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 |
Company profile
- Canonical name
- Boston Scientific Corporation
- Aliases
- Boston Scientific, Boston Scientific Corp
- Country
- United States(US)
Cited predicates
4- K170121
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
- K210925
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
- K100078
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Not ingested - K110685
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Not ingested
Boston Scientific Corporation references 4 predicate/reference devices
Cited as predicate
1- K251759
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