# K170867: FTRD System Set

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Jul 25, 2017 after 124 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K240274: PADLOCK CLIP EFTR Kit (00713229) (2024), 1 descendant of its own
- K253481: colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (2026), 0 descendants of its own
- K250842: PADLOCK CLIP EFTR Kit (00713229) (2025), 0 descendants of its own

## Indications for use
FTRD System: Instrument designed for flexible endoscopy. Instrument is designed for diagnostic tissue acquisition and full-thickness resection through the removal of suitable lesions in the colon and rectum. The FTRD System 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. FTRD Marking Probe: Instrument for marking tissue using superficial HF coagulation in flexible endoscopy. FTRD Grasper: Instrument for flexible endoscopy for grasping and manipulation of tissue in the gastrointestinal tract, e.g. during interventions with the FTRD System.

Source page: https://510kreport.com/device/K170867
Methodology: https://510kreport.com/methodology