# K250927: KARL STORZ Cholangiography Set

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Nov 22, 2025 after 239 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943435 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943435: Cholangiography Set, Karl Storz Endoskop GmbH (1994) Summary page 5.

## Indications for use
The KARL STORZ Cholangiography Set consists of manually operated reusable surgical devices intended for use by qualified surgeons in minimally invasive intraoperative cholangiography in adults and pediatric patients ≥13 years of age.

Source page: https://510kreport.com/device/K250927
Methodology: https://510kreport.com/methodology