# K222354: Elastic Traction System

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Oct 3, 2022 after 60 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
Longest line of descent: 1 generation back to DEN220006 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220006: ProdiGI, Covidien, LLC (2022) Summary page 5.

## Indications for use
The Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the stomach and colon.

Source page: https://510kreport.com/device/K222354
Methodology: https://510kreport.com/methodology