Accu-Chek Safe-T-Pro Uno Lancing Device— 510(k) K232509
Substantially EquivalentRoche Diabetes Care, Inc.
FDA 510(k) clearance K232509 for Accu-Chek Safe-T-Pro Uno Lancing Device, Substantially Equivalent on 2023-11-13. Applicant: Roche Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diabetes Care, Inc.
- Product code
- Code FMK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code FMK
view allMore clearances from Roche Diabetes Care, Inc.
view allAdverse events under product code FMK
product code FMK- Injury
- 133
- Malfunction
- 1,278
- Other
- 1
- Total
- 1,412
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.