Arc Endocuff Vision— 510(k) K151801
Substantially EquivalentBoddingtons Plastics, Ltd.
FDA 510(k) clearance K151801 for Arc Endocuff Vision, Substantially Equivalent on 2015-08-13. Applicant: Boddingtons Plastics, Ltd.. Device class: 2.
Clearance details
- Applicant
- Boddingtons Plastics, Ltd.
- Product code
- Code FED
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tonbridge, GB
Recent devices under product code FED
view allMore clearances from Boddingtons Plastics, Ltd.
view allAdverse events under product code FED
product code FED- Death
- 10
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K151801
K-number listed on FDA's recall record- Z-2423-2021 — 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; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy
- 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151801.
Data sourced from openFDA. This site is unofficial and independent of the FDA.