K262631
- 510(k) number
- K262631
- Device name
- Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
- Applicant
- SteriLance Medical (Suzhou), Inc. CN
- Product code
- QRK — Single Use Only Blood Lancet Without An Integral Sha
- Decision date
- 2026-08-25
- Date received
- 2026-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K262631.pdf
Official FDA record: K262631
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.