K250016
- 510(k) number
- K250016
- Device name
- droplet® personal lancets
- Applicant
- Htl-Strefa S.A PL
- Product code
- QRK — Single Use Only Blood Lancet Without An Integral Sha
- Decision date
- 2025-07-01
- Date received
- 2025-01-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K250016.pdf
Official FDA record: K250016
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.