# K241858: BARS Set (100.60)

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Aug 26, 2024 after 60 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: 5 generations back to K963160 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101428: Otsc (Over-the Scope-Clip) System Set, Ovesco Endoscopy AG (2010) Summary page 5.

## Most influential descendants
- K251562: OTSCneo System Set (100.03n-14n, 100.27n-31n) (2025), 0 descendants of its own

## Indications for use
The BARS Set is indicated for clip placement within the context of flexible endoscopy in the Gl tract for the purpose of: - Hemostasis for: - Mucosal/submucosal defects < 3 cm - Arteries <2 mm - Treatment of luminal perforations (< 20 mm) and / or anastomoses (< 50 mm) - Lumen reduction NOTE: The BARS Set is not indicated for stent fixation. For stent fixation, use the stentfix OTSC System Set.

Source page: https://510kreport.com/device/K241858
Methodology: https://510kreport.com/methodology