# K192566: Reach and CQ'ENCE Circular Staplers

- Pathway: 510(k) (Special)
- Applicant: Reach Surgical, Inc.
- Decided: Oct 17, 2019 after 29 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K940967 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
6 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120179: Reach Surgical Staplers, Reach Surgical, Inc. (2012) Summary page 4.

## Indications for use
The CQ’ENCE Circular Staplers have application throughout the alimentary tract for the creation of end-to-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries.

Source page: https://510kreport.com/device/K192566
Methodology: https://510kreport.com/methodology