Instylla Delivery Kit
FDA 510(k) clearance K253769 · decided 2025-12-22
Clearance details
- K-number
- K253769
- Device name
- Instylla Delivery Kit
- Applicant
- Instylla, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-25
- Decision date
- 2025-12-22
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Embrace Hydrogel Embolic System (HES) (P250003/S002) | Instylla, Inc. | 2025-12-17 |
| Embrace(TM) Hydrogel Embolic System (P250003/S001) | Instylla, Inc. | 2025-11-25 |
| Embrace(TM) Hydrogel Embolic System (P250003) | Instylla, Inc. | 2025-08-05 |