# K122565: Arc Endocuff

- Pathway: 510(k) (Traditional)
- Applicant: Boddingtons Plastics, Ltd.
- Decided: Sep 4, 2012 after 13 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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
Longest line of descent: 3 generations back to K853585 (1986). 10 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984358: Olympus Distal Attachment, Models MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597, Olympus America, Inc. (1999) Summary page 1.
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15, Fujinon, Inc. (2009) Summary page 1.

## Most influential descendants
- K133359: Endorings (2014), 1 descendant of its own
- K190030: Embrella Endoscopic Distal Attachment (2019), 0 descendants of its own
- K162205: Arc EndoCuff and Arc EndoCuff Vision (2016), 0 descendants of its own
- K160846: AmplifEYE (2016), 0 descendants of its own

## Indications for use
To be attached to the distal end of the endloscope to facilitate endloscopic therapy, to be used for the following: * Keeping the suitable depth of endloscope's view field * Helping the endloscope with being inserted into the gastrointestinal tract

Source page: https://510kreport.com/device/K122565
Methodology: https://510kreport.com/methodology