Justright Surgical, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1956-2015 | Class II | JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed w | June 11, 2015 |
| Z-1955-2015 | Class II | JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed wi | June 11, 2015 |
| Z-2690-2014 | Class II | Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 produc | August 27, 2014 |
| Z-2691-2014 | Class II | Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replaceme | August 27, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160602 | JustRight Surgical Vessel Sealing System | June 23, 2016 |
| K132472 | JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD | February 11, 2014 |
| K123662 | THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM | May 22, 2013 |