Company ยท GB
Boddingtons Plastics, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2020. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2020 | K191330 | Arc Enterocuff Boddingtons Plastics, Ltd., GB | FDA |
| May 30, 2019 | K191067 | Arc Endocuff Glide AEG110 & AEG120 Boddingtons Plastics, Ltd., GB | FED |
| Dec 9, 2016 | K162205 | Arc EndoCuff and Arc EndoCuff Vision Boddingtons Plastics, Ltd., GB | FED |
| Aug 13, 2015 | K151801 | Arc Endocuff Vision Boddingtons Plastics, Ltd., GB | FED |
| Sep 4, 2012 | K122565 | ARC ENDOCUFF Boddingtons Plastics, Ltd., GB | FED |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2020 | Boddingtons Plastics Ltd Endocuff Vision: models ARV 110, 120, 130, 140
Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during end Terminated |
FED | K151801 |