HydroPearl
Bland Beads
1manufacturer
12catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | MicroVention, Inc., United States |
|---|---|
| FDA product code | NAJ |
| Device type | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K150870 |
| Record published | 2018-08-07 |
| Record revised | 2026-04-28 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HP2S0600 | 2 ml, 600 µm | In distribution |
| HP2S0200 | 2 ml, 200 µm | In distribution |
| HP2S1100 | 2 ml, 1100 µm | In distribution |
| 8HP2S600 | 2 ml, 600 µm | In distribution |
| HP2S0800 | 2 ml, 800 µm | In distribution |
| HP2S0400 | 2 ml, 400 µm | In distribution |
| 8HP2S1100 | 2 ml, 1100 µm | In distribution |
| 8HP2S400 | 2 ml, 400 µm | In distribution |
| 8HP2S75 | 2 ml, 75 µm | In distribution |
| 8HP2S200 | 2 ml, 200 µm | In distribution |
| 8HP2S800 | 2 ml, 800 µm | In distribution |
| HP2S0075 | 2 ml, 75 µm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Embosphere® | Biosphere Medical, Inc. | 24 |
| Embozene Microspheres (Opaque) | Celonova Biosciences, Inc. | 20 |
| Embozene Microspheres (Color-Advanced) | Celonova Biosciences, Inc. | 20 |
| Contour™ | Boston Scientific Corporation | 14 |
| Bearing nsPVA® | Merit Medical Systems, Inc. | 7 |
| Cook | Cook Incorporated | 2 |
| Embozene Color Advance 700um Embozene 1mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 900um Embozene 1mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 500um Embozene 2mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 250um Embozene 2mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 250um Embozene 1mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 1300um Embozene 1mL Colored – US | Varian Medical Systems, Inc | 1 |
Showing 12 of 18. All products under Agents, Embolic, For Treatment Of Uterine Fibroids
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| MicroVention, Inc. | 510(k) number | 2023-12-21 | Class II | Device Design | Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. | 22 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.