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510(k) Data Aggregation
(29 days)
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(239 days)
The KARL STORZ Cholangiography Set consists of manually operated reusable surgical devices intended for use by qualified surgeons in minimally invasive intraoperative cholangiography in adults and pediatric patients ≥ 13 years of age.
The KARL STORZ Cholangiography Set are manually operated reusable surgical devices consisting of: Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet. The KARL STORZ Cholangiography Set includes devices which are used to facilitate the execution of cholangiograms (x-ray pictures of the bile ducts) during endoscopic surgery.
The Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet work together to ensure accurate and clear cholangiography during minimally invasive procedures.
- The Cholangiography Fixation Clamp secures the catheter in place after insertion, preventing movement and ensuring proper positioning.
- The Guide Tube provides a smooth, controlled pathway for the catheter during insertion.
- The BERCI Plastic Stylet eliminates metal shadows by remaining in place when the metal trocar sheath is removed, preserving clear X-ray imaging of the biliary system.
The devices facilitate precise catheter placement, reduce interference in imaging, and maintain optimal procedure conditions for successful cholangiography.
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(447 days)
The Nuvis Wireless HD Camera System is indicated for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity of the body.
The Nuvis Wireless HD Camera System (or "System" or "Nuvis-2K") consists of two wireless reusable camera heads that can be paired to a wireless base station. When the camera head is attached to an arthroscope/light source (using a C-mount coupler) AND the wireless base station is attached to a clinic supplied video system, arthroscopic examinations can be viewed and pertinent data recorded. A tablet with NuvisCon Application (APP) can be connected to the wireless base station to enter patient and case data. The System can transmit uncompressed video content from the camera head to the wireless base station up to 5 meters (15 feet) away. Recorded video and snapped pictures are saved to an internal storage drive in the wireless base station.
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(88 days)
Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.
Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.
The system is composed of four main components:
- An obturator that facilitates insertion of the system through an incision.
- A cannula with bolster and attached balloon, encased within a perforated sheath.
- A seal which maintains insufflation.
- An inflation bulb that is used to manually inflate and deflate the balloon.
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(63 days)
Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures.
Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts.
Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Stellar Imaging System comprises Image Processing Unit, Light Source, Camera Head, Laparoscope and relevant accessories. During surgical procedures, Stellar Imaging System is used to provide real-time 3D visible and fluorescence imaging in endoscopic surgery.
The Stellar Imaging System including the laparoscope is designed to work with an approved infrared dye (Indocyanine green (ICG). ICG may be excited at excitation at either 785 or 805 nm. The System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye via the camera head. Fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow, etc.
The System allows the capture of normal (white) light image in parallel with the fluorescence image and displays both to the surgeon to provide a view of the anatomy. In addition, the System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.
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(60 days)
The VereSee Optical Veres Needle and Endoscopic Camera is intended for:
• Percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic surgery
• Use as an endoscopic video camera to provide visible light imaging in a variety of endoscopic and laparoscopic diagnostic and surgical procedures
The VereSee Optical Veres Needle and Endoscopic Camera System consists of two components: 1) VereSee Optical Veres Needle and Endoscopic Camera, and 2) VereSee Camera Control Unit.
The VereSee Optical Veres Needle and Endoscopic Camera consists of a series of three concentric stainless steel cannulas with a handle and an umbilical cable to connect it to the VereSee Camera Control Unit. It is provided sterile, for single patient use. The three concentric stainless steel cannulas include: 1) an Outer Cannula (or Insufflation Cannula), 2) a Central Cannula (or Access Cannula) with a clear, pointed tip for penetration and visualization during body cavity entry, and 3) Inner Cannula (or Camera Cannula) with a CMOS camera surrounded by light fibers at its tip.
The VereSee Camera Control Unit connects the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to HDMI compatible monitors to provide an image for endoscopic procedures. The VereSee Camera Control Unit (CCU) includes an LED driver to power the LED. The CCU connects to the Optical Veres Needle and Endoscopic Camera via an umbilical cable. The CCU converts signals from the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to a format compatible with HDMI display input requirements.
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(111 days)
The Arthrex Synergy Vision imaging system is intended to provide visible light imaging in a variety of diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.
The Arthrex Synergy Vision imaging system is indicated for use to provide real-time visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform open and minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision imaging system is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Additionally, the system is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision imaging system is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision imaging system is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The Arthrex NanoNeedle Scope when used with the Synergy Vision imaging system is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.
The Arthrex 4K Open Scope 0° NIR is intended to be used as an accessory with the Synergy Vision imaging system to provide visible light imaging and near-infrared fluorescence imaging during open surgical procedures.
The Synergy Vision Imaging System includes a camera control unit (CCU) console, camera head, scope, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging.
The Synergy Vision Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the scope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.
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(284 days)
The Revolve Surgical System is intended to assist in the control of Revolve Surgical laparoscopic instrument for endoscopic manipulation of tissue, including approximation, ligation, and suturing, during laparoscopic general surgery. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use.
The Revolve Surgical System is an electromechanically controlled laparoscopic surgery platform used for minimally invasive surgery in the abdomen comprised of a reusable system arm which mounts to the operating table and several sterile, single-use disposable accessories – instrument, instrument handle, and drape. The device operates under the direct control of the surgeon to manipulate tissues during surgery. Surgeon control is achieved by grasping the instrument handle and moving it to the desired position. The device compensates for gravitational forces applied to the instrument and maintains the instrument position when the surgeon's hand is removed from the device.
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(219 days)
It is used to connect with an optical endoscope during the endoscopic diagnosis, treatment, and observation. And to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.
The 4K Endoscopic Camera System consists of a camera control unit and a 4K camera head.
The device is intended to be used to connect with an optical endoscope during the endoscopic diagnosis and/or treatment/surgery, and to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.
There are 4 models of the device. The hardware configuration of the device of 4 models are same, and difference is different functions which opened up through software.
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(108 days)
The LaproSac™ Specimen Retrieval Bags is indicated for use in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery.
The SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval Systems are sterile single patient use devices, which comprise of a flexible nylon bag with and without a deployment mechanism. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists for an introducer and actuation rod with biasing arms, which allows for insertion through an appropriately sized port and automatic opening of the bag upon deployment.
These devices are not made with natural rubber latex or synthetic derivatives of natural rubber latex.
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