K261045
- 510(k) number
- K261045
- Device name
- Verifine Safety Lancets
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd. CN
- Product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps
- Decision date
- 2026-05-01
- Date received
- 2026-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K261045.pdf
Official FDA record: K261045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.