# K251562: OTSCneo System Set (100.03n-14n, 100.27n-31n)

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Dec 18, 2025 after 210 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: 6 generations back to K963160 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101482: EM-9000, Elite Medical, Inc. (2011) Summary page 5.
- K183309: stentfix OTSC System Set, Ovesco Endoscopy AG (2019) Summary page 5.
- K241858: BARS Set (100.60), Ovesco Endoscopy AG (2024) Summary page 5.

## Indications for use
Instrument for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions. Marking of lesions. * The OTSCneo clip is indicated for clip placement within the 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 - Diverticuli in the colon * Closure of GI tract luminal perforations < 20 mm that can be treated conservatively. NOTE: The OTSCneo System Set is not indicated for stent fixation. For stent fixation, use the stentfix OTSC® System Set.

Source page: https://510kreport.com/device/K251562
Methodology: https://510kreport.com/methodology