# K151801: Arc Endocuff Vision

- Pathway: 510(k) (Special)
- Applicant: Boddingtons Plastics, Ltd.
- Decided: Aug 13, 2015 after 42 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162205: Arc EndoCuff and Arc EndoCuff Vision (2016), 0 descendants of its own
- K160846: AmplifEYE (2016), 0 descendants of its own

## Recalls of this device
- Aug 3, 2021 · Class II · Z-2423-2021: Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
- Mar 11, 2020 · Class II · Z-1718-2020: Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)

## Indications for use
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: •Keeping the suitable depth of endoscope’s view field •Helping the endoscope with being inserted into the gastrointestinal tract

Source page: https://510kreport.com/device/K151801
Methodology: https://510kreport.com/methodology