The following data is part of a premarket notification filed by Boston Scientific with the FDA for Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse Id Laser Fiber, Flexiva Pulse Id Tractip Laser Fiber.
| Device ID | K210925 |
| 510k Number | K210925 |
| Device Name: | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Boston Scientific 300 Boston Scientific Way Marlborough, MA 01564 |
| Contact | Rebecca Perrine |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-04-28 |