K233796
- 510(k) number
- K233796
- Device name
- Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
- Applicant
- SteriLance Medical (Suzhou), Inc. CN
- Product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps
- Decision date
- 2024-01-16
- Date received
- 2023-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233796.pdf
Official FDA record: K233796
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.