# K140763: Monofilament Polypectomy Snare

- Pathway: 510(k) (Special)
- Applicant: United States Endoscopy
- Decided: Apr 24, 2014 after 28 days
- Product code: FDI (Snare, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jul 14, 2015 · Class II · Z-0001-2016: The company has determined the sterility cannot be assured for the affected lot.

## Indications for use
The US Endoscopy Monofilament polypectomy snare is an electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (01) endoscopic procedures.

Source page: https://510kreport.com/device/K140763
Methodology: https://510kreport.com/methodology