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510(k) Data Aggregation
(184 days)
The C-Lant Port is intended for use in a variety of endoscopic procedures to provide a port of entry into the abdominal and thoracic cavities.
The C-Lant Port is a sterile, single-use access system comprised of a trocar and a port with a self-fixating element, designed to provide a secure and sealed port of entry into the thoracic or abdominal cavity during a variety of endoscopic procedures. The device incorporates a retractable blade trocar for controlled penetration, which automatically re-sheaths to reduce the risk of internal injury once the cavity is accessed. Upon withdrawal of the delivery system, an internal fixation element expands into a flower-like configuration that anchors the device against the inner wall, while an external fixation disk with a soft foam interface prevents over-insertion. The integrated iris sealing mechanism rotates to provide a hermetic seal around catheters or tubes up to and including 28Fr, allowing reliable drainage or instrument passage without leakage.
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(74 days)
The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Universal Seal (5-12 mm) is a sterile, single-use device. It provides a seal within a port of entry for endoscopes, instruments, and accessories with a diameter range between 5 mm and 12 mm. It also provides an attachment for insufflation accessories and allows for air to flow in or out of the body cavity while minimizing gas leakage.
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(28 days)
1688 Camera 4K Camera System with Advanced Imaging Modality:
The 1688 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery, spine surgery, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1688 4K Camera System with Advanced Imaging Modality is indicated for adults and pediatric patients.
A few examples of the more common endoscope surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node detection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
1788 Camera 4K Camera System with Advanced Imaging Modality:
The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery, spine surgery, and plastic surgery whenever a laparoscope/ endoscope/arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.
A few examples of the more common endoscope surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node detection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
Stryker's Advanced Imaging Modality (AIM) System includes the 1688 4K Camera System with AIM and 1788 4K Camera System with AIM, which are endoscopic camera systems that produces live video in the surgical field during surgical endoscopic procedures.
The 1688 4K Camera System with AIM is sensitive in the visible white light and infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1788 4K Camera System with AIM is sensitive in the visible white light, infrared spectrums and short blue spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 and 1788 4K Camera Systems consist of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.
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(22 days)
The Saberscope™ Laparoscope is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.
The Saberscope™ Laparoscope device contains two separate functioning components. First is the single-use, sterile Saberscope™ Laparoscope Device, which includes a 0° camera on a 5 mm rigid shaft with a ± 90° articulating tip, 36 cm long shaft, and high-definition video image. The second is the Xenocor® VPU which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view.
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(220 days)
It is intended for use under endoscopic visualization for the morcellation and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.
The device includes a control unit, handpiece, footswitch, blades, waste bottle, collection bottle, and suction tube. The device is a reusable morcellation device which is intended for use under endoscopic visualization for the morcellation and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures.
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(129 days)
The CO2 Pneumo-Dissector is used to dissect planes of soft tissue using pressure regulated, trigger-controlled pulses of medical grade CO2 gas. The device may be used in endoscopic, laparoscopic, and open procedures in which gentle blunt dissection of soft tissue planes is desired. Use the product only in accordance with the instructions provided.
The Pneumo Dissector Hook is a standard monopolar hook (based on design cleared under K140101) that can deliver CO2 flow on demand during general endoscopy and laparoscopic surgery. It is composed of two parts, a handle and an insert, which are linked using a nut-screw system. Also, the distal part of the instrument has the hook shape which is the monopolar electrode and the gas nozzle. It is a surgically invasive device intended for delivering pressurized CO2 gas to achieve separation of tissue layers prior to their dissection. The hook insert and tube are offered in lengths of 330mm and 200mm and diameters of 3.5mm and 5.0mm.
The handle has a connector for the CO2 as well as the banana plug or connector for electrosurgery. There is a push button to activate the CO2.
The nut-screw system is used to link the handle to the insert.
The insert consists of an insulated tube with a hook on the distal end.
The hook insert and tube are available in lengths of 330mm and 200mm and diameters of 3.5mm and 5.0mm.
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(29 days)
Connected OR Hub with Device and Voice Control:
The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.
SDC4K Information Management System with Device and Voice Control:
The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.
The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected devices both wired and wirelessly.
The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consist of the following components:
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Base Console which includes:
a. Medical Device Data System (MDDS) functionalities
b. Optional Device Control feature
c. Optional Voice Control feature
d. Optional Video Image Processing (VIP) feature -
Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
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Voice Control Package (software activation USB dongle and a wireless headset and base station)
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Video Image Processing package (software activation USB dongle)
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Connected OR Spoke (MDDS)
The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e., non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control and/or Voice Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.
In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Medical Device Data System. Once the Connected OR Hub or SDC4K Information Management System Console is connected to the Spoke, Device Control and Voice Control can be extended to compatible devices which are directly connected to the Spoke. Ethernet-compatible devices are connected to the Secondary Spoke via an ethernet cable/switch.
When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm and removal of surgical smoke through a compatible insufflator.
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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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