Boddingtons Plastics, Ltd.
Tonbridge, Kent, GB
Boddingtons Plastics, Ltd. appears in FDA device records in Tonbridge, Kent, GB. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Boddingtons Plastics, Ltd. between 2012 and 2020. The busiest year on record is 2012, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191330 | Arc Enterocuff | FDA | Substantially Equivalent | |
| K191067 | Arc Endocuff Glide AEG110 & AEG120 | FED | Substantially Equivalent | |
| K162205 | Arc EndoCuff and Arc EndoCuff Vision | FED | Substantially Equivalent | |
| K151801 | Arc Endocuff Vision | FED | Substantially Equivalent | |
| K122565 | ARC ENDOCUFF | FED | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1718-2020 | 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 endocosopic therapy by manipulating colonic folds | Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device) | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain