K253605
- 510(k) number
- K253605
- Device name
- Safety Heel Lancet
- Applicant
- Ningbo Medsun Medical Co., Ltd. CN
- Product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps
- Decision date
- 2026-02-20
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.2 MB · U.S. public domain
Also available from FDA: K253605.pdf
Official FDA record: K253605
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.