510(k) K210925 ยท GEX Powered Laser Surgical Instrument
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
| Applicant | Boston Scientific, Marlborough MA, US |
| Decision | Substantially Equivalent, Apr 28, 2021 |
| Received | Mar 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2023 | Boston Scientific Corporation Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy.
Single-pack UPN : M006L8405910 Open, Classified |
GEX | None listed |
| Jul 21, 2023 | Boston Scientific Corporation Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy
Single-pack UPN : M006L8405960 Open, Classified |
GEX | None listed |
| Jul 21, 2023 | Boston Scientific Corporation Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy.
5-pack UPN: M006L8405961 Open, Classified |
GEX | None listed |
| Jul 21, 2023 | Boston Scientific Corporation Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy
Single-pack UPN: M006L8406910 Open, Classified |
GEX | None listed |
| Jul 21, 2023 | Boston Scientific Corporation Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy
(Box of 5)UPN: M006L8406911 Open, Classified |
GEX | None listed |
| Jul 21, 2023 | Boston Scientific Corporation Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy
(Single-pack UPN): M006L8406960 Open, Classified |
GEX | None listed |
| Jul 21, 2023 | Boston Scientific Corporation Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy
5-pack UPN: M006L8406961 Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.