# K260003: KARL STORZ Mediastinoscopes and Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Mar 2, 2026 after 59 days
- Product code: EWY (Mediastinoscope, Surgical)
- Device class: 2
- Regulation: 21 CFR 874.4720
- 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 K954910 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954910: Karl Storz Optical Mediastinoscope, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 5.
- K971166: Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece, Richard Wolf Medical Instruments Corp. (1997) Summary page 5.
- K213194: HD Mediastinoscope, Karl Storz Endoscopy America, Inc. (2022) Summary page 5.

## Indications for use
For devices (10970A, 10970B, 10970DS, 10973HD) Intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during endoscopic surgical procedures in adults and pediatric patients = 12 years of age. For devices (10900G0O,10900GP, 10900GR, 10900M, 10900MO, 10900MP, 10970, 10970G0O, 10970GOL, 10970GP, 10970GPL, 10970GR, 10970GRL, 10970H, 10970K, 10970M, 10970ML) The instruments are intended for lymph node biopsy, removal of lymphatic nodes and tumors, grasping and dissecting tissue for diagnosis and treatment of pleural, parenchymal and mediastinal disease in adults and pediatric patients = 12 years of age.

Source page: https://510kreport.com/device/K260003
Methodology: https://510kreport.com/methodology