Embrace(TM) Hydrogel Embolic System
FDA premarket approval P250003 · decided 2025-08-05
Approval details
- PMA number
- P250003
- Trade name
- Embrace(TM) Hydrogel Embolic System
- Generic name
- Embolization Agent, Vascular
- Applicant
- Instylla, Inc.
- Date received
- 2025-02-06
- Decision date
- 2025-08-05
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- QVG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- The Embrace Hydrogel Embolic System (HES) is indicated for embolization of hypervascular tumors in peripheral arteries ? 5mm.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Verge™ Microcatheter (K261610) | Instylla, Inc. | 2026-06-11 |
| Instylla Delivery Kit (K253769) | Instylla, Inc. | 2025-12-22 |
| Tembo Embolic System (K253677) | Instylla, Inc. | 2025-12-15 |
| TEMBO Embolic System (K240873) | Instylla, Inc. | 2024-12-16 |
| Instylla Delivery Kit (K213632) | Instylla, Inc. | 2022-02-10 |
| Instylla Microcatheter 1.2 (K210808) | Instylla, Inc. | 2021-04-15 |
| Instylla Delivery Kit (K202544) | Instylla, Inc. | 2021-01-07 |
| Instylla Microcatheter (K200744) | Instylla, Inc. | 2020-04-21 |