K232509
- 510(k) number
- K232509
- Device name
- Accu-Chek Safe-T-Pro Uno Lancing Device
- Applicant
- Roche Diabetes Care, Inc. IN · US
- Product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps
- Decision date
- 2023-11-13
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K232509.pdf
Official FDA record: K232509
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.