Embrace(TM) Hydrogel Embolic System
FDA premarket approval P250003/S001 · decided 2025-11-25
Approval details
- PMA number
- P250003
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Embrace(TM) Hydrogel Embolic System
- Generic name
- Embolization Agent, Vascular
- Applicant
- Instylla, Inc.
- Date received
- 2025-09-11
- Decision date
- 2025-11-25
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- QVG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- approval to implement a minimum packaging configuration of 2 shelf boxes/shipper
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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 |