K260248
- 510(k) number
- K260248
- Device name
- Ultra-Fast Warm
- Applicant
- Kitazato Corporation JP
- Product code
- MQL — Media, Reproductive
- Decision date
- 2026-04-28
- Date received
- 2026-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K260248.pdf
Official FDA record: K260248
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.