Search Results

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 (10900GO,10900GP, 10900GR, 10900M, 10900MO, 10900MP, 10970, 10970GO, 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.

The Mediastinoscopes and Instruments submitted in this 510(k) consist of two (2) variants of mediastinoscope devices and compatible instruments relative to either variant:

1. Mediastinoscopes and Adaptor: 10970A, 10970B with optional adapter 10970DS and
2. HD Mediastinoscope: 10973HD
3. Forceps:
   a. Forceps inserts: 10900GO, 10900GP, 10900GR, 10900M, 10900MO, 10900MP
   b. Outer sheath: 10970
   c. Biopsy Forceps: 10970GO, 10970GOL, 10970GP, 10970GPL, 10970GR, 10970GRL, 10970H
   d. Sponge and Dissecting Forceps: 10970K, 10970M, 10970ML

MEDIASTINOSCOPES AND ADAPTOR
The surgical stainless steel mediastinoscopes (10970A, 10970B) are non-powered, reusable surgical instruments consisting of a compact handle integrated with a rigid sheath terminating in a spatula-shaped (beveled) distal geometry to provide access to and visualization of the mediastinum and a working channel for atraumatic entry of surgical instrumentation. They rely on externally connected optical and illumination components for visualization and contain no active electronic components.

Visualization may be accomplished either via

1. A light carrier inserted into the mediastinoscopes and connected to an external light source for direct visualization of the surgical field or
2. A surgical stainless steel adaptor (10970DS) attached to the proximal end of the sheath, enabling insertion of a compatible rigid telescope into the mediastinoscopes, which is connected to an external light source and compatible camera heads and control unit (CCU) to provide video visualization of the surgical field.

Note: The mediastinoscopes are a non-spreadable design and may be used with a light carrier.

HD MEDIASTINOSCOPE
(Identical to the HD Mediastinoscope 10973HD cleared under K213194)

The HD Mediastinoscope (10973HD) is comprised of four main components: a CMOS sensor located at the distal end of the endoscope, an oval insertion portion (spatula), a handle, and an internal LED light source. The subject device is unchanged in design, materials, dimensions, optical characteristics, and illumination performance when compared to the HD Mediastinoscope (10973HD) cleared under K213194.

The only difference between the subject device and the cleared device is an expansion of the indicated patient population to include adolescents >=12 years of age.

INSTRUMENTS
The KARL STORZ Mediastinoscopes and Instruments, including forceps and accessories, are manually operated, reusable surgical devices 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.

Forceps and sheaths are integral accessories that enable the mediastinoscope to perform its intended diagnostic and therapeutic functions. Sheaths provide a protective channel and maintain visualization while allowing instrument passage, whereas forceps deliver essential capabilities for grasping, cutting, and biopsy of tissue. In combination these instruments complement the mediastinoscope design by facilitating safe tissue manipulation and sampling without requiring additional incisions, ensuring the system operates as a complete solution for mediastinal, pleural, and parenchymal procedures.

N/A

Ask a specific question about this device