Flexiva Pulse Laser Fiber +3 more— 510(k) K251759
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K251759 for Flexiva Pulse Laser Fiber +3 more, Substantially Equivalent on 2025-07-09. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Device name as filed
- Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
- Applicant
- Boston Scientific Corporation
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlborough, MA, US
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More clearances from Boston Scientific Corporation
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.