FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OBSIDIO Conformable Embolic (M0013972101010)
K Number: K253376
·
Decision Oct 30, 2025
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
231
Review Days
30
Basic Information
- Device Name
- OBSIDIO Conformable Embolic (M0013972101010)
- K Number
- K253376
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- September 30, 2025
- Decision Date
- October 30, 2025
- Product Code
- KRD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRD), ordered by most recent decision date.
HARBOR Occlusion Device
FDA 510(k)
FDA Class 2
·Cardiovascular
LOBO Vascular Occlusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
Concerto Versa Detachable Coil
FDA 510(k)
FDA Class 2
·Cardiovascular
Tembo Embolic System
FDA 510(k)
FDA Class 2
·Cardiovascular
Polyvinyl Alcohol Embolic Microspheres
FDA 510(k)
FDA Class 2
·Cardiovascular
HARBOR Occlusion Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Boston Scientific Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K260428 | RIVOS EUS Access Device (M00553900) | Jun 17, 2026 | Substantially Equivalent |
| K260100 | MOSES Raydar | May 18, 2026 | Substantially Equivalent |
| K260771 | TruSelect 2.6 Microcatheter | May 15, 2026 | Substantially Equivalent |
| K251273 | Asurys Fluid Management System | Mar 27, 2026 | Substantially Equivalent |
| K260479 | TheraSphere 360 Y-90 Management Platform | Mar 13, 2026 | Substantially Equivalent |
| K260119 | SpaceOAR Vue System (SV-2101) | Feb 10, 2026 | Substantially Equivalent |
| K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Oct 30, 2025 | Substantially Equivalent |
| K252547 | TheraSphere 360 Y-90 Management Platform | Oct 28, 2025 | Substantially Equivalent |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Sep 26, 2025 | Substantially Equivalent |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | Sep 24, 2025 | Substantially Equivalent |