# K191330: Arc Enterocuff

- Pathway: 510(k) (Traditional)
- Applicant: Boddingtons Plastics, Ltd.
- Decided: Jan 31, 2020 after 260 days
- Product code: FDA (Enteroscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

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

Source page: https://510kreport.com/device/K191330
Methodology: https://510kreport.com/methodology