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The B7-2C Occlusion Balloon is to be used for selective endoscopic bronchography, saline injection associated with bronchoalveolar lavage, bronchial hemostasis and airway occlusion to localize air leaks.

The device is introduced through the instrument channel of the bronchoscope. The device is constructed of the inflatable balloon, catheter, bifurcation, irrigation port, air feed cap and stopcock. The B7-2C device is 1050 mm in working length, with a pre-inflation diameter of 2.55 mm and a post-inflation diameter of 13 mm, with a max volume of 1.7 cc.

The Spiration ANET Electrosurgical Applicator is indicated for coagulation of soft tissue when used in conjunction with a compatible radiofrequency generator.

The Active Needle Endoscopic Treatment (ANET) Applicator (Model # ANET-00) is a disposable bipolar electrosurgical applicator intended for the coagulation and necrosis of soft tissue. Each Applicator consists of a needle (proximal electrode) with a coil (distal electrode). The needle and coil serve as the bipolar electrodes, so there is no need for an external ground pad. The ANET Applicator is compatible with the cleared Olympus ESG-100 Electrosurgical Generator (K072307) and endoscopes with a working inner diameter of 2.2mm or greater, such as those cleared in K093395 and K100584. Other radiofrequency generators will be added as compatibility is established. To perform ablation, the flexible catheter portion is first inserted into a compatible ultrasound endoscope working channel, then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a mechanism locking onto the single use adapter biopsy valve. The handle facilitates advancement of the needle/proximal electrode during puncture of the targeted ablation site. Once the proximal electrode is positioned, a separate handle control facilitates advancement of the distal electrode. Saline and power connections at the handle of the device deliver fluid (1-3cc/min) and energy respectively to the distal portion of the device. The needle size of the device is 19 gauge (19G). During operation, radiofrequency (RF) current is passed between the distal electrode and the proximal electrode to thermally coagulate the tissue. The ANET device is provided sterile and is intended for single patient use. The device should only be used within a healthcare setting by physicians knowledgeable and experienced in RF ablation.

This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

The PeriFLEX Needle is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. The device is supplied sterile and intended for single patient use. The main components of the device are a handle, a sheath, a needle, and a stylet. The sheath and needle (together termed the insertion portion) are attached to the handle. The removable stylet runs the full length of the device and fits inside the lumen of the handle and the needle. The needle is housed within the sheath. These components, i.e., the insertion portion, are inserted into the working channel of the endoscope and advanced to the target site. The handle is connected to the insertion and has a needle slider component. The needle slider is controlled manually by the user to extend and retract the needle from the sheath at the target site. Once a sample is collected, the stylet may be used to assist with removing the sample from the needle. The PeriFLEX Needle is available in one model only (PERIFLEX-21G), with a needle size of 21 gauge (21G). The PeriFLEX Needle can be used with the following accessories: vacuum syringe (to assist with sample collection), biopsy valve (to assist with creating a vacuum), and guide sheath (to extend the working length). However, these accessories are not included with the PeriFLEX Needle's packaging and must be obtained separately by the user.

The ViziShot FLEX has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose of the than its intended use.

The ViziShot FLEX is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use. The device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although the device has a component called a needle, the device is often referred to as a needle as well. Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve. The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing. The ViziShot FLEX is available in one model only (NA-U402SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Olympus Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot FLEX.

The Flexible 19G EBUS Needle has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

The Flexible 19G EBUS Needle is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use. The device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. To perform biopsies, the flexible catheter portion is first inserted into a bronchoscope's working channel (2.2mm) then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope using an adapter biopsy valve. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal of the handle. The device is available with a needle size of 19 qauqe (19G).