Bead Block
FDA 510(k) K150876 · Biocompatibles UK , Ltd.
510(k) numberK150876
Submission
- Device name
- Bead Block
- Applicant
- Biocompatibles UK , Ltd.
Farnham, GB - Received
- April 1, 2015
- Decision date
- March 7, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
More from Nuvascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K162373 | LC Bead LUMIKRD · Traditional | 12/16/2016SE |
| K152157 | LC Bead LUMIKRD · Traditional | 12/11/2015SE |
| K094018 | LC Bead Microspheres, Bead Block Compressible MicrospheresHCG · Special | 04/16/2010SE |
| K083091 | LC Bead Microspheres, Bead Block Compressible MicrospheresKRD · Traditional | 12/24/2008SE |
| K042231 | Gelspheres Microspheres and Bead Block Compressible MicrospheresHCG · Traditional | 11/12/2004SE |
| K033761 | Gelspheres / Beadblock Compressible MicrospheresHCG · Traditional | 02/04/2004SE |
Questions and answers
When was Bead Block cleared by the FDA?
Bead Block (K150876) received a 510(k) decision of Substantially Equivalent on March 7, 2016, 341 days after the submission was received.
What is the product code of K150876?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.