510(k) K253677
- Device
- Tembo Embolic System
- Applicant
- Instylla, Inc.
- 510(k) number
- K253677
- Product code
- KRD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-15
- Date received
- 2025-11-21
- Regulation
- 870.3300
- Classification name
- Device, Vascular, For Promoting Embolization
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jennifer Greer
- Address
- 201 Burlington Rd. North Bldg. Bedford MA US 01730 01730
FDA Registration Numbers#
- 9615728
- 3000143502
- 3033589330
- 3012931345
- 9614654
- 3010178296
- 2024311
- 1423662
- 2184009
- 2032112
- 3008853977
- 3012276280
- 3042953152
- 1531062
- 1820334
- 3008307705
- 2133641
- 2134265
- 3005735987
- 3017961114
- 3015615738
- 3007029079
- 3012179728
- 3002808486
- 1048735
- 1721676
- 3015531723
- 3005168196
- 1000121056
- 1000393132
- 3002807314
- 3006950086
- 3016444913
- 3012536737
- 3013505221
- 3005580113
- 3031240343
- 3010173425
- 3007738736
- 3004859241
- 1721504
- 3012448339
- 3008264254
- 3009905888
- 3030003849
- 3004091615
- 2183870
- 2024024
- 1220477
- 3027595249
- 3007113487
- 3015453963
- 3007628272
- 3013353964
- 3011137372
- 2183744
- 1928237
- 3008114965
- 3013556777
- 2020394
- 3008881809
- 3012120143
- 3031550970
- 3015151147
- 3015225571
- 2030598
- 3013944123
- 3005111382
- 3016609702
- 2134812
- 3016591327
- 3016245399
- 2030624
- 2953359
- 1424778
- 3009526575
- 3016688836
- 3044156918
- 3008262715
Source Documents#
Other 510(k) Records For Product Code KRD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261866 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026-06-24 |
| K260635 | HARBOR Occlusion Device | Nuvascular, Inc. | 2026-06-12 |
| K260508 | LOBO Vascular Occlusion System | Okami Medical, Inc. | 2026-04-10 |
| K253511 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026-01-14 |
| K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) | Boston Scientific Corporation | 2025-10-30 |
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | 2025-09-23 |
| K250133 | HARBOR Occlusion Device | Nuvascular, Inc. | 2025-07-09 |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | 2025-05-30 |
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | 2025-05-16 |
| K250276 | Nitinol Enhanced Device (NED) | Embolization, Inc. | 2025-05-15 |
| K250079 | Ruby XL System | Penumbra, Inc. | 2025-03-14 |
| K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | 2025-01-17 |
| K240873 | TEMBO Embolic System | Instylla, Inc. | 2024-12-16 |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | 2024-10-16 |
| K242507 | OBSIDIO™ Conformable Embolic | Boston Scientific | 2024-10-03 |