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Precision GI is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a motorized, automated, rotational, cutting EUS-Biopsy needle with an echogenic tip inserted and operated through the instrument channel of an ultrasound imaging endoscope. The Limaca Precision GI FNB needle is available in one size - 20G. The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a battery-operated, motorized, automated rotational cutting biopsy device with an echogenic needle tip, advanced and operated by the physician through the accessory instrument channel of an ultrasound imaging endoscope.

The Clear Tip is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

The ClearTip is a manually operated endoscopic instrument intended to obtain tissue specimens of gastrointestinal tract (=digestive tract) and tracheobronchial tree. The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. This device passes through a working channel of an endoscope, and the average contact time with the submucosal or external lesions of a gastrointestinal tract or a tracheobronchial tree is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.

This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

The EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is an endoscopic ultrasound needle consisting of a needle assembly and syringe. The needle assembly is comprised of a handle, sheath, stylet and needle cannula. This device is available in one 22Ga needle size.

The EndoDrill® Model X is intended to be used with an ultrasound endoscope for ultrasonically guided fine needle sampling of submucosal- and extramural lesions within gastrointestinal tract (i.e. esophagus, mediastinal masses, stomach, pancreas, liver, small- and large intestines, lymph nodes and perirectal masses). This device is for diagnostic purposes only.

The EndoDrill® Model X biopsy instrument consists of a single-use handle with a flexible sheath and a cylinder tip that can be rotated to collect tissue samples. An outer sheath covers the tip to facilitate smooth insertion, positioning of the instrument and extraction. The hollow cylinder allows for multiple samples being taken continuously without removing the instrument for harvesting between biopsies. Rotation is facilitated by an isolated reusable electrical motor controlled by the user. No current, heat, smoke or sparks are introduced into the patient. The device is designed to be used in flexible endoscopic instruments with ultrasound (EUS) used for examinations of the gastrointestinal tract. The single-use biopsy instrument consists of a needle and handle that are supplied sterile and is for single patient use only. The needle contains all patient contact pathways and is fully disposable. Cleaning, reprocessing and/or re- sterilization of the instrument is prohibited. The needle is inserted through the working channel of a flexible endoscope and fixed at the endoscope handle. The single-use and handle consists of the following pre-assembled, sterile components: 1. A biopsy needle consisting of stainless-steel with a coring cylinder tip collecting samples in a fluid- and airtight tubing when rotated. 2. An outer sheath that surrounds the rotating needle and may be used to place the inner needle at the biopsy site. 3. A handle that is mounted to the working channel of an endoscope, used to control sampling and attaches to a reusable drive cable that mechanically transfers rotation. The reusable electrical motor and drive cable facilitating the rotation of the tip are supplied non-sterile and reusable. The motor unit contains an on/off safety switch and rotation is activated with a pedal attached to the motor. The drive cable that mechanically transmits rotation to the needle is mounted on the handle prior to sampling. The motor unit accommodates a DC motor which includes a power indicator light and attachments for power cable, drive cable and pedal. The motor is isolated and provides mechanical rotation to the single-use handle via the drive cable. No current, heat, smoke or sparks are introduced into the patient.

Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The disposable biopsy refill needle (hereinafter referred to as refill needle) is divided into A and B in accordance with different configuration. A contains biopsy refill needle. B contains biopsy refill needle and coaxial biopsy needle. The disposable biopsy refill needle consists of stylet housing, stylet, canular housing, fixation parts, canula and protecting sheath. It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, pale blue= 12G). The needles have a protecting sheath. The Disposable Biopsy Refill Needle is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen. The materials used for construction of Disposable Biopsy Refill Needle is typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

Disposable Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.

The disposable coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping, stylet housing and protecting sheath. It is available in several gauge sizes and lengths. The disposable coaxial biopsy needle (hereinafter referred to as coaxial biopsy needle) is divided into 11G、13G、15G、17G、19G in accordance with the outer diameter of canula and 70mm、78mm、100mm、130mm、138mm、170mm、170mm and 178mm in accordance with the length of canula. The materials used for construction of disposable coaxial biopsy needle are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. The disposable coaxial biopsy needle can be used with the matching biopsy needle under the guidance of medical imaging, as a channel for other biopsy needles to enter the body and obtain biopsy samples through negative pressure or cutting for clinical diagnosis or treatment. In clinical practice, doctors sometimes repeatedly puncture the target site for biopsy. At this time, the coaxial needle is configured, which provides a channel that the device can take multiple samples at the target site. That avoids repeated puncture and injury on the patient's skin surface. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

The EchoTip® Ultra Endoscopic Ultrasound Needle is used with an ultrasound endoscope for fine needle aspiration (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. The EchoTip ProCore® HD Ultrasound Biopsy Needle is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Olympus scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA). Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Pentax scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA). Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Olympus scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract. Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Pentax scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree.

EchoTip Ultra Endoscopic Ultrasound Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 22 and 25 Ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The purpose of the needle cannula is for puncturing of the target site. The preloaded nitinol stylet is withdrawn from the needle when obtaining sample from the target site. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in sample aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only. EchoTip ProCore HD Ultrasound Biopsy Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 20, 22 and 25 ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and a notch. The purpose of the needle cannula is for puncturing/biopsy of the target site. The preloaded nitinol stylet is withdrawn from the needle for biopsy. Some variants have a stylet that coils when not in the needle. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in tissue aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only. EchoTip Ultra / ProCore Endobronchial High Definition Ultrasound Needle: These Needles are used in conjunction with an endobronchial ultrasound endoscope and is available with needle gauge sizes of 22 and 25 Ga. The device is composed of a needle assembly and a syringe. An adapter can also be supplied for use with endobronchial ultrasound endoscopes with metal non-Luer hubs. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and comes either with or without a notch. The purpose of the needle cannula is for puncturing/sampling of the target site. The needle is provided with a preloaded stylet which remains in place during advancement of the needle. The sheath covers the needle when the needle is retracted and not in use. The device handle allows for needle and sheath length adjustment. The stylet/syringe can aid in specimen retrieval. The device is supplied sterile and intended for single use only. The device is for Rx use only.

The Biopsy Needle is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone. The Biopsy Needle is also indicated to provide breast tissue sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Biopsy Needle are used to remove, by cutting, a specimen of tissue for microscopic evaluation. The organs in which the device may be used include but are not limited to breast, kidney, liver, prostate, spleen and lymph nodes plus various soft tissue masses. As the device is single use device, which is individually packaged sterile devices. In the package, there is a whole device with the structure shown in the picture above without any accessories. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

As a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Gangi-SoftGuard Coaxial Needle together with Gangi-HydroGuard Coaxial Needle forms the Gangi Coaxial Needle family. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are manually operated, sterile, single use coaxial guiding needles with a spring loaded blunt-tip stylet, to be used as a guiding needle for biopsy instruments in procedures in soft tissue. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle has the same intended use. Coaxial Needle and Gangi-SoftGuard Gangi-HydroGuard Coaxial Needle are gastroenterological, manually operated, sterile, single use coaxial introducer needles. Both Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle consists of three parts: a needle (cannula) provided with a trocar stylet, and a spring-loaded blunt tip stylet. The difference from Gangi-SoftGuard Coaxial Needle is that Gangi-HydroGuard Coaxial Needle has a Luer hub located on the blunt stylet housing and the blunt stylet is hollow and has a distal tip hole. This enables injection of fluid without the need to remove the blunt stylet.