# K253481: colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Sep 14, 2026 after 335 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
Longest line of descent: 1 generation back to K170867 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170867: FTRD System Set, Ovesco Endoscopy AG (2017)
- K200684: gastroduodenal FTRD Set, Ovesco Endoscopy AG (2020) Summary page 5.

## Indications for use
colonic FTRD Set and diagnostic FTRD Set: Instrument for flexible endoscopy, for full thickness resection and diagnostic tissue acquisition through the removal of suitable lesions in the colorectum. The colonic FTRD is indicated for the resection of lesions < 3 cm in the colon and rectum. Resection sizes may be less than 3 cm due to targeted tissue thickness and degree of fibrosis. The diagnostic FTRD is indicated for the resection of lesions < 2.5 cm in the colon and rectum. Resection sizes may be less than 2.5 cm due to targeted tissue thickness and degree of fibrosis. gastroduodenal FTRD Set: 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/K253481
Methodology: https://510kreport.com/methodology