Search Results
Found 1320 results
510(k) Data Aggregation
(24 days)
Ask a specific question about this device
(60 days)
Ask a specific question about this device
(90 days)
Ask a specific question about this device
(59 days)
Ask a specific question about this device
(59 days)
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
Endoscopic ICG System
Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients ≥1 month of age, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients ≥ 12 years of age, using near infrared imaging in accordance with the appropriately indicated endoscope.
Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG 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 KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Exoscopic ICG System
VITOM ICG SYSTEM
The KARL STORZ VITOM ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures in adults and pediatrics ≥ 1 month of age.
The VITOM ICG System is intended to provide a magnified view of the surgical field.
RUBINA Lens System
The RUBINA Lens System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures in adults and pediatrics ≥ 1 month of age.
Upon interstitial administration and use of the ICG consistent with its approved label, the RUBINA Lens System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon intradermal administration and use of the ICG consistent with its approved label, the RUBINA Lens System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults undergoing breast surgical procedures for which fluorescence imaging is a component of intraoperative management.
The RUBINA Lens System is intended to provide a wide-angle view of the surgical field.
The RUBINA® Lens supports anatomical visualization under white light and NIR/ICG fluorescence. Its native 16:9 full-screen image eliminates the need for digital zoom, enabling shorter working distances that help maintain fluorescence signal capture during procedures requiring continuous visualization of lymphatic or perfusion-related structures.
The device incorporates a wide-angle optical design and expanded focus range, supporting consistent imaging across variable working distances for applications such as:
- Fluorescence-guided assessment of tissue perfusion
- Visualization of lymphatic pathways and sentinel lymph nodes
The RUBINA® Lens features a 90° direction of view and may be used handheld or mounted to a compatible holding arm. Rotation of the attached camera head allows horizon adjustment to maintain anatomical orientation.
The system provides continuous white-light and NIR/ICG visualization for display on standard operating room monitors. The device achieves optimal illumination at approximately 18 cm and maintains fluorescence visualization across a broad working distance range, supporting use in applications such as perfusion assessment and lymphatic mapping.
The subject device RUBINA® Lens is compatible with the following components within the KARL STORZ ICG Imaging System:
- IMAGE1 S™ Rubina® camera head (TH121) previously cleared on K201399 and K202925.
- IMAGE1 S™ Camera Control Unit (CCU) (TC201US, TC304US) previously cleared on K212695, K201135, K233333, K232857.
- Fiber Light Cables (495NCSC, 495TIP): used to transmit visible and NIR light from the Power LED Rubina Light Source (TL400) to the RUBINA® Lens. The 495NCSC was previously cleared K201399, and K202925. The 495TIP Fiber Light Cable was most recently cleared in K233333.
- The Power LED Rubina® Light Source (TL400) previously cleared in K201399, K202925, K212695, K232857, and K233333. The TL400 is included as a subject device, as the KARL STORZ ICG Imaging System Indications for Use reflected in the TL400 labeling require revision within this 510(k). No modifications have been made to the TL400 with respect to materials, technological characteristics, performance, reprocessing, or any other essential design features.
- Footswitch (UF101): [Optional] Previously cleared in K201399, K202925, K212695, and K232857.
N/A
Ask a specific question about this device
(268 days)
The Konig Bell Circumcision clamps are reusable instruments used in a medical procedure to compress the foreskin of the penis during the circumcision of male infant or child. Use of the Konig Bell Circumcision clamps in adults is to assist in Human Immunodeficiency Virus (HIV) prevention.
The Konig Bell Circumcision Clamp is intended to be used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant, child or adult. The device is manufactured from Germangrade 304 stainless steel and is composed of four parts: base, bell, hook arm and thumb screw. The device is offered in the following bell sizes 0.8cm, 1.1cm, 1.3cm, 1.45cm, 1.6cm, 2.1cm, 2.6cm, 2.9cm, 3.2cm and 3.5cm.
The Konig Bell Circumcision Clamp is packaged in a low-density polyethylene film pouch. The device is provided non-sterile and is intended to be cleaned and sterilized at the healthcare facility prior to use. Validated cleaning and steam sterilization instructions are included in the instructions for use.
N/A
Ask a specific question about this device
(92 days)
The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum and other anterior chest wall deformities. It is indicated for use in adult and pediatric (children and adolescents) populations.
The KLS Martin Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum and other anterior chest wall deformities. The implants are provided non-sterile in multiple sizes and are manufactured using traditional manufacturing methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also includes the necessary instruments to facilitate placement of the implants.
The purpose of this submission is as follows:
-
Line extension to include the Pectus Stabilizer
-
Add "MR Conditional" to the device labeling for the Pectus Stabilizer used in conjunction with pectus bar.
-
Expand the Indications for Use to include other anterior chest wall deformities such as Pectus Carinatum and Pectus Arcuatum
N/A
Ask a specific question about this device
(60 days)
The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.
The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).
The purpose of this premarket notification is to expand the Ixos system to include anatomically pre-contoured plates designed to conform to the dorsal aspect of the radius, the distal ulna, and the shaft portions of both the radius and ulna. These plates will be available in both left and right configurations. In addition, new sizers will be introduced to the current Ixos system to assist with intraoperative selection and placement.
N/A
Ask a specific question about this device
(219 days)
The KneeVoice Cartilage Evaluation System is intended to be used as a part of physical assessment of a patient by healthcare professional for diagnostic decision support in clinical settings. It is intended to be used by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the patellofemoral section of the knee.
The Kneevoice™ Cartilage Auscultation System (CAS) is a system that captures the sounds and vibrations emitted by the articular cartilage during joint motion. The Kneevoice CAS device consists of an audio and position sensor assembly cabled to a digital console. The console consists of an enclosure, power components, a touch screen display, a processor and memory. The console is mounted to a desktop stand. In use, the audio and position sensor assembly is attached to the top of the patient's patella using the disposable self-adhesive patches. The audio sensor listens to the sounds produced by the patellofemoral joint while the patient flexes their knee eight times from a 0 to 90 degree range of motion. The audio and position sensor electronics send the sound and motion data to the console over a cable. The console receives the data stream and performs noise reduction, band-pass filtering and pattern recognition.
N/A
Ask a specific question about this device
(270 days)
The KabiHelp® Bag is an empty container to be filled with components of parenteral nutrition and parenteral nutrition related medication to be administered to the patients using an intravascular administration set. Parenteral nutrition and parenteral nutrition related medication transfer in and out of the container is done using aseptic technique.
The KabiHelp® Bag is an empty plastic container to be filled with components of parenteral nutrition and parenteral nutrition related medication to be administered to patients using an intravascular administration set. It is designed to be used with KabiHelp Pro Compounding System and KabiHelp Transfer Sets and Accessories.
Filling of the bags takes place in an aseptic environment. The bags are available in monolayer or multilayer models in various volumes.
All KabiHelp bags are equipped with three port types: (1) a filling port suitable for the KabiHelp Transfer Sets, (2) an injection port for manual injection of additives, and (3) an administration port for infusion therapy.
N/A
Ask a specific question about this device
Page 1 of 132