# K153550: FTRD System Set

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Oct 12, 2016 after 306 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
DTC Snare: The DTC Snare is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions. The clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: - Endoscopic marking - Hemostasis for: - Mucosal/submucosal defects < 3 cm - Bleeding ulcers - Arteries < 2 mm - Polyps < 1.5 cm in diameter - Diverticula in the colon - Closure of GI tract luminal perforations < 20 mm that can be treated conservatively The snare is an instrument for flexible endoscopy for grasping and removing tissue in the gastrointestinal tract. Marking Probe: Instrument for marking tissue using superficial HF coagulation in flexible endoscopy. Grasper: Instrument for flexible endoscopy for grasping and manipulation of tissue in the gastrointestinal tract, e.g. during interventions with the DTC Snare.

Source page: https://510kreport.com/device/K153550
Methodology: https://510kreport.com/methodology