# K200684: gastroduodenal FTRD Set

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Jun 2, 2020 after 78 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K253481: colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (2026), 0 descendants of its own

## Indications for use
Instrument for flexible endoscopy, for full-thickness resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum. The gastroduodenal FTRD is indicated for the resection of lesions < 2.5 cm in the stomach and duodenum. Resection sizes may be less than 2.5 cm due to target tissue thickness and degree of fibrosis. For the resection of subepithelial tumors (SETs) the resection size is limited by the inner cap diameter.

Source page: https://510kreport.com/device/K200684
Methodology: https://510kreport.com/methodology