Boston Scientific Corporation

Country / region:United States (US)

510(k) submissions

4

Latest clearance

2026-05-18

Product codes

1
GEX

Cited as predicate

1

Product areas

FDA product code distribution

510(k) submissions

4 total

K numberDevice nameProduct codeClassDecision date
K260100MOSES Raydar™GEXClass 22026-05-18
K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)GEXClass 22025-10-30
K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser FibersGEXClass 22025-07-09
K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser FiberGEXClass 22021-04-28

Company profile

Canonical name
Boston Scientific Corporation
Aliases
Boston Scientific, Boston Scientific Corp
Country
United States(US)

Cited predicates

4

Boston Scientific Corporation references 4 predicate/reference devices

Cited as predicate

1

1 submission cite Boston Scientific Corporation as a predicate