# DEN220006: ProdiGI

- Pathway: De Novo (Direct)
- Applicant: Covidien, LLC
- Decided: Jun 13, 2022 after 150 days
- Product code: QSW (Endoscopic Traction Device)
- Device class: 2
- Regulation: 21 CFR 876.4410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K222354: Elastic Traction System (2022), 0 descendants of its own

## Indications for use
The Medtronic ProdiGI Traction Wire is indicated to grasp tissue within the esophagus, stomach, and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure. The Medtronic ProdiGI Traction Magnet is indicated to grasp tissue within the stomach and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.

Source page: https://510kreport.com/device/DEN220006
Methodology: https://510kreport.com/methodology