# K183309: stentfix OTSC System Set

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Oct 22, 2019 after 327 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
- K251562: OTSCneo System Set (100.03n-14n, 100.27n-31n) (2025), 0 descendants of its own

## Indications for use
Instrument for flexible endoscopy for fixation of metal stents in the gastrointestinal tract for use in adults only.

Source page: https://510kreport.com/device/K183309
Methodology: https://510kreport.com/methodology