# K971166: Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Aug 27, 1997 after 149 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: 1 generation back to K954910 (1995). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 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 1.
- (no number) Fiber Light Mediastinoscope 8960.01/.03: named in the summary without a submission number
- (no number) Mediastinoscope “CARLENS™” 10970A/B and operating instruments: named in the summary without a submission number

## Most influential descendants
- K141622: Illuminated Mediastinoscope (2015), 2 descendants of its own
- K160171: Illuminated Mediastinal Access Port (2016), 1 descendant of its own
- K260003: KARL STORZ Mediastinoscopes and Instruments (2026), 0 descendants of its own
- K170757: Aegis Transit System (2017), 0 descendants of its own

## Indications for use
The Mediastinoscope, in connection with various auxiliary instruments, is used for diagnostic and/or surgical interventions in the upper area of the mediastinum. Mediastinoscopy is carried out: - In order to evaluate the operability of patients suffering from bronchial carcinoma which have already been verified, for treatment planning of other carcinomas in the mediastinal area and for biopsies. - For diagnostic clarification of primary and secondary diseases of the mediastinum, when other examination methods have been unable to provide the nature, and in particular the histological character of the disturbance. - For the removal of nodes and tumors. - For the diagnosis and removal of lymphatic nodes. Various auxiliary instruments are used in mediastinoscopy: The smoke evacuation tube is used to evacuate smoke during HF or laser applications. The telescope rinsing tube (optic irrigation tube) is used to keep the distal area of the telescope clear by rinsing with irrigation fluid. The mediastinal puncture tube is used to puncture lymph nodules and aspirate the content for cyto/histological purposes. The tumor grasping forceps are used for grasping and manipulating tissue. The micro grasping forceps with HF are used for coagulating small vessels and grasping. The HF coagulation suction devices are used for suction and for coagulation while holding tissue ‘out of the way’ during endoscopic operations of the larynx in connection with CO₂ lasers or in mediastinoscopy. The bipolar aspiration tube (bipolar coagulation suction tube) is used for aspiration and for coagulation of small lesions.

Source page: https://510kreport.com/device/K971166
Methodology: https://510kreport.com/methodology