K260191
- 510(k) number
- K260191
- Device name
- Safety lancet (XXXVII)
- Applicant
- Tianjin Huahong Technology Co., Ltd. CN
- Product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps
- Decision date
- 2026-03-31
- Date received
- 2026-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K260191.pdf
Official FDA record: K260191
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.