# K191878: DEX Device

- Pathway: 510(k) (Traditional)
- Applicant: Dex Surgical
- Decided: Jan 29, 2021 after 564 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K910831 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061425: Purewrist Scissors, Model PW1101-01;Purewrist Dissector,  Model PW1201-01;Purewrist Hook, Model PW1301-01, Cambridge Endoscopic Devices (2006) Summary page 4.

## Indications for use
The DEX device laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, suturing, transection and electro-cauterization of tissues.

Source page: https://510kreport.com/device/K191878
Methodology: https://510kreport.com/methodology