K252289
- 510(k) number
- K252289
- Device name
- Eva Scalp Cooling System
- Applicant
- Stemtech Medical Devices Private Limited IN
- Product code
- PMC — Scalp Cooling System
- Decision date
- 2025-11-25
- Date received
- 2025-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252289.pdf
Official FDA record: K252289
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.