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The InjecSURE® Injection System is intended for use as an accessory to currently marketed cystoscopes to allow delivery of injectable materials into urethral tissues of the lower urinary tract during cystoscopic procedures.

The InjecSURE Injection System includes sterile, single-use components designed for one patient, featuring a 20 Ga, 5-inch (127 mm) needle—available with either a pencil-point or spinal tip—and a disposable sheath. The disposable sheath is compatible with 2.7 mm cystoscopes of various lengths.

The sheath attaches to a cystoscope to provide a guided pathway for the needle to reach the desired location.

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Endoscopes:
Cystoscopes/Hysteroscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Cystoscopes/Hysteroscopes are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

Urology Instruments:
The Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The instruments are intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

Cystoscopes, Hysteroscopes and Accessories are composed of cystoscopes, hysteroscopes and cystoscopic accessories, which provide the user with the means for endoscopic diagnostic and therapeutic procedures. Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.

The subject device includes the following components:

• Cystoscope /Hysteroscopes: A rigid or flexible endoscopic instrument designed for direct visualization of the urethra and urinary bladder. It consists of an optical system (telescope), an illumination source, and working channels that allow the introduction of instruments for diagnostic and therapeutic procedures such as biopsies, stone removal, or stent placement.

• Sheaths – Outer tubular component that serves as the access conduit during cystoscopy. It provides irrigation and drainage channels to maintain clear visualization, and allows for the introduction of instruments into the bladder. The sheath connects with the bridge and obturator to form the working assembly.

• Obturators – A smooth-tipped guiding element inserted through the cystoscopic sheath to facilitate atraumatic insertion into the urethra. Once access is achieved, the obturator is removed, allowing the sheath to remain in place for the procedure.

• Visual Obturator – A specialized obturator with an optical channel that accommodates the telescope, enabling direct visualization during insertion. It ensures safe, controlled advancement of the sheath under continuous endoscopic view.

• Bridge – An intermediate component that connects the cystoscopic sheath to the telescope and accessory instruments. It provides ports for irrigation and instrument entry, enabling controlled manipulation during diagnostic and therapeutic procedures.

• Albarran deflectors: A built-in mechanical deflection mechanism located in the bridge or sheath assembly. It allows precise angulation and control of accessory instruments, such as guidewires or forceps, facilitating access to the ureteral orifices.

• Optical Forceps: Endoscopic grasping instruments equipped with an integrated optical channel for direct visualization during tissue manipulation or foreign body retrieval. They enable precise control and visualization through the telescope.

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The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System - Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.

Each instrument consists of four primary components: the housing, shaft, wrist, and tip. The shaft and wrist enable multiple axes of articulation, while the tip is designed for direct interaction with tissue. When operated in conjunction with the appropriate robotic system, these instruments provide enhanced dexterity and a greater range of motion than the human hand, facilitating precise tissue manipulation and dissection in minimally invasive procedures.

The remanufactured devices are intended for up to ten (10) additional clinical use cycles beyond the OEM-cleared use life, as supported by validated reprocessing and performance testing. The design, materials, and intended use are identical to the Predicate Device (K131861) in form, fit, and function. The mechanism of action is unchanged and remains based on the same fundamental mechanical architecture and dimensions.

There are no changes to:

• The indications for use
• Clinical applications
• Patient population
• Performance specifications
• Method of operation

In accordance with the Design Control process, a comprehensive risk analysis was conducted to evaluate the impact of remanufacturing. The remanufacturing process includes validated inspection, repair, testing, and cleaning procedures to ensure safety and effectiveness. Design verification and validation activities confirmed that the Subject Devices meet all applicable design input requirements. The following evaluations were performed, or rationales were provided where testing was not required, consistent with applicable standards and FDA guidance:

• Biocompatibility (per ISO 10993)
• Functional performance testing (mechanical and electrical)
• Cleaning validation (including protein, hemoglobin, and TOC residue analysis)
• Electrical safety testing (per IEC 60601-1 and relevant clauses)

Test results support that the remanufactured instruments are as safe and effective as the Predicate Devices and meet all required specifications for intended use.

Additionally, FDA-cleared Reference Device (K203632) is cited to support the validated cleaning and reprocessing methods associated with the proposed ten (10) reuse cycles.

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Disposable Distal Cap is used with the cholangioscope and installed to the distal end of cholangioscope to keep appropriate endoscopic field of view.

Disposable Distal Cap is used with the cholangioscope and installed to the distal end of cholangioscope to keep appropriate endoscopic field of view. Disposable Distal Cap is a single structural product, with 2 types, which are cylinder type and taper type. For each type, we have 1 specification, totally 2 specifications. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterile maintenance package to ensure a shelf life of 1 year.

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The da Vinci Force Feedback Instruments are 8 mm, multi-use endoscopic instruments intended to be used with the da Vinci Surgical System, Model IS5000. These instruments have an articulating wrist that gives surgeons natural dexterity and range of motion, and possess the ability to render forces measured at the instrument tip to the hand controls at the Surgeon Console of the IS5000 System. Each instrument performs one or more surgical tasks such as suturing, grasping, and tissue manipulation.

Indications for use of the da Vinci Force Feedback Instruments are covered as part of the da Vinci Surgical System, Model IS5000. The most recent cleared indications for use, which are not anticipated to be modified in the upcoming 510(k), are listed for reference below.

Da Vinci Surgical System, Model IS5000:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Contraindication:

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

The da Vinci Force Feedback Instruments are 8 mm, multi-use, endoscopic instruments intended for use with the da Vinci Surgical System, Model IS5000. These instruments have been designed with an articulating wrist that gives surgeons natural dexterity and range of motion, and have the ability to render forces measured at the instrument tip to the hand controls at the system Console.

The devices listed in Table 1 below are the subject devices of this premarket notification, which Intuitive intends to introduce into interstate commerce in accordance with 21 CFR Section 807.81.

Table 1: Subject Devices

Model Number Device Description
477006 da Vinci Force Feedback Large Needle Driver
477049 da Vinci Force Feedback Cadiere Forceps
477093 da Vinci Force Feedback ProGrasp Forceps
477172 da Vinci Force Feedback Maryland Bipolar Forceps
477205 da Vinci Force Feedback Fenestrated Bipolar Forceps
477309 da Vinci Force Feedback Mega SutureCut Needle Driver

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a) ED-S100TP, ED-S100XP
This product has been designed for endoscopy and endoscopic surgery within the duodenum.

b) VS-1000
This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope.

a) ED-S100TP/ED-S100XP
This product is a medical electronic side viewing endoscope for duodenum, and it is inserted into the lumen, coelom, body cavity, or inside of the body, which provides images for observation, diagnosis, photographing, or treatment. The device is used for observation, diagnosis and treatment of the duodenum, in medical institutions under the supervision of a physician. The device is equipped with bending part which enables to move the distal end part in 4 different directions such as up and down, right and left. The device consists of a flexible tube with the bending part, and the operating part with the lever to operate the bending part. The tube inside of the flexible tube is installed from the operating part to the distal end part. Inserting treatment tools into the conduit line (referred as 'forceps channel') enables trans-endoscopic treatment.
This product is a sterile single-use device and is not intended for reprocessing.

b) VS-1000
This product has image processing, light source control, AE (shutter) control functions, a connector for endoscopes, and a connector for display units, and provides images for observation, diagnosis, photography, or treatment in body cavities by connecting the display unit and endoscope.

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The CVAC Image Processor is only to be used with the CVAC Aspiration System to provide treatment and removal of urinary stones (kidney stones, fragments, and dust) and endoscopic examination of the urinary tract and the interior of the kidney.

The CVAC Image Processor, the subject device, is a software-controlled, reusable and electrical image processor. The CVAC Image Processor is connected to a standard 110V hospital electrical outlet via a provided power cord. The internal carrier board inside the CVAC Image Processor houses the LED control circuit, the display interface, and supports electrical interconnect between the image signal processing module and the System-on-Module (SOM). This allows the CVAC Image Processor to generate a video signal compatible with standard hospital grade external monitors. Accessories provided with the CVAC Image Processor include a HDMI-to-DVI adapter, a HDMI cable, and a power cable. The CVAC Image Processor software is updated to v1.5 in this submission.

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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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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.

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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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