Boddingtons Plastics Ltd
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1718-2020 | Class II | Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached | March 11, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191330 | Arc Enterocuff | January 31, 2020 |
| K191067 | Arc Endocuff Glide AEG110 & AEG120 | May 30, 2019 |
| K162205 | Arc EndoCuff and Arc EndoCuff Vision | December 9, 2016 |
| K151801 | Arc Endocuff Vision | August 13, 2015 |
| K122565 | ARC ENDOCUFF | September 4, 2012 |