# K254228: KARL STORZ Trocars with Valve Seals

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: May 11, 2026 after 136 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: 2 generations back to K940347 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180977: KARL STORZ New Generation Trocars, KARL STORZ Endoscopy-America, Inc. (2018) Summary page 5.

## Indications for use
KARL STORZ Trocars with Valve seals are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.

Source page: https://510kreport.com/device/K254228
Methodology: https://510kreport.com/methodology