K261634
- 510(k) number
- K261634
- Device name
- Disposable Blood Lancet (Soft)
- Applicant
- SteriLance Medical (Suzhou), Inc. CN
- Product code
- QRK — Single Use Only Blood Lancet Without An Integral Sha
- Decision date
- 2026-06-12
- Date received
- 2026-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261634.pdf
Official FDA record: K261634
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.