K244036
- 510(k) number
- K244036
- Device name
- Heel Incision Safety Lancet (SteriHeel 2)
- Applicant
- SteriLance Medical (Suzhou), Inc. CN
- Product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps
- Decision date
- 2025-02-26
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K244036.pdf
Official FDA record: K244036
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.