510(k) K151801 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Arc Endocuff Vision
| Applicant | Boddingtons Plastics, Ltd., Tonbridge, GB |
| Decision | Substantially Equivalent, Aug 13, 2015 |
| Received | Jul 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2021 | Olympus Corporation of the Americas Arc Endocuff Vision as follows:
ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501;
ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500;
ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502;
AR Terminated |
FED | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.