MOSES Raydar— 510(k) K260100
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K260100 for MOSES Raydar, Substantially Equivalent on 2026-05-18. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
Boston Scientific's MOSES Raydar is filed under GEX, powered laser surgical instruments. The record doesn't describe it beyond its name and that code name.
Class II, 21 CFR 878.4810. The Gastroenterology and Urology review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Boston Scientific filed from Marlboro, Massachusetts. The decision came 125 calendar days after receipt (January 13 to May 18, 2026).
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Product 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
- Traditional
- Location
- Marlboro, MA, US
Recent devices under product code GEX
view allMore 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.