K253677
- 510(k) number
- K253677
- Device name
- Tembo Embolic System
- Applicant
- Instylla, Inc. MA · US
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2025-12-15
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253677.pdf
Official FDA record: K253677
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.