Instylla, Inc.
Medical device manufacturer in Bedford, MA.
10510(k) clearances
1PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261610 | Verge MicrocatheterKRA · Special | 06/11/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | 12/22/2025SE |
| K253677 | Tembo Embolic SystemKRD · Special | 12/15/2025SE |
| K240873 | TEMBO Embolic SystemKRD · Traditional | 12/16/2024SE |
| K213632 | Instylla Delivery KitFMF · Special | 02/10/2022SE |
| K210808 | Instylla Microcatheter 1.2KRA · Special | 04/15/2021SE |
| K202544 | Instylla Delivery KitFMF · Special | 01/07/2021SE |
| K200744 | Instylla MicrocatheterKRA · Special | 04/21/2020SE |
| K191659 | Instylla Delivery KitFMF · Traditional | 10/10/2019SE |
| K191731 | Instylla MicrocatheterKRA · Traditional | 08/13/2019SE |
PMA approvals
- P250003 Embrace(TM) Hydrogel Embolic System · 08/05/2025 · 7 supplements