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510(k) Data Aggregation
K Number
K213610Device Name
Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps
Manufacturer
Katalyst Surgical, LLC
Date Cleared
2022-10-07
(326 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Katalyst Surgical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kogent Disposable Copper Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Copper Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue. The Kogent Disposable Copper Illuminating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and to supply light for surgical procedures.
Device Description
These devices are disposable bipolar forceps, designed for single use in general surgical procedures. They require connection with a suitable bipolar cable to the bipolar output of an electrosurgical generator. These forceps are designed to grasp, manipulate, coagulate, irrigate and illuminate, when applicable, selected tissues. The irrigation tube is designed to carry sterile fluid to the tips of the instrument. The illumination style forceps contain illumination fibers on each tine to deliver light to the surgical site. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The forceps are provided sterile by ethylene oxide and in sterile pouches.
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K Number
K192963Device Name
Kogent Torus Ultrasonic Aspirator
Manufacturer
Katalyst Surgical, LLC
Date Cleared
2020-06-19
(240 days)
Product Code
LFL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Katalyst Surgical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kogent TorUS® Ultrasonic Aspirator system is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue and hard tissue (e.g. bone) is desired, including Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, and Thoracoscopic Surgery.
Device Description
The Kogent TorUS® consists of a console that provides power and control of the ultrasonic aspiration and irrigation functions, three surgical handpieces that provide the ultrasonic mechanical energy to the surgical site, a foot pedal to allow the user control over the ultrasonics, titanium tips (variety of models), irrigation sleeves, suction/irrigation system (manifold tubing and a vacuum canister) and accessories used for assembly and reprocessing. The Kogent TorUS accommodates most commercially available suction canisters and optional specimen traps.
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K Number
K163632Device Name
Katalyst Cyclophotocoagulation Probe
Manufacturer
Katalyst Surgical, LLC
Date Cleared
2017-06-15
(175 days)
Product Code
LQJ, FFS, MPA
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
Katalyst Surgical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.
Device Description
The Cycloprobe is a single use device sold sterile. The Cycloprobe is made out of one fiberoptic, one laser machine connector, one handle for surgeon manipulation, one clear tip for placement on the eye, and a protective sheath over the fiber. On the distal side, the fiberoptic is terminated by a connector that attaches to the laser machine. On the other side, it is terminated by a fiber that has a ball lens formed onto the end that protrudes slightly from the clear tip. The connector configuration is chosen based on the surgeons' laser machine requirements. The total length of the device is 7 feet.
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K Number
K141781Device Name
KOGENT SPETZLER LIGHTED SUCTION TUBES
Manufacturer
KATALYST SURGICAL, LLC
Date Cleared
2015-04-09
(281 days)
Product Code
HBI, FST
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
KATALYST SURGICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kogent™ Spetzler Lighted Suction Tubes are intended to provide surgical site illumination from a high intensity light source.
Device Description
This device is a disposable Kogent™ Spetzler Lighted Suction Tubes, designed for single use in surgical procedures. Lighted Suction Tubes require connection with a suitable operating room suction system to deliver suction as well as with a suitable illumination machine. Lighted Suction Tubes are designed to provide illumination while having the ability to aspirate the surgical site. The devices are provided sterile by Ethylene Oxide and in sterile packaging.
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K Number
K140362Device Name
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
Manufacturer
KATALYST SURGICAL, LLC
Date Cleared
2014-09-15
(215 days)
Product Code
HQF, HQB, MPA
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
KATALYST SURGICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments.
The Revolver Laser Probes can only be used with a medical laser at operating wavelengths of 500nm to 900mm. The Revolver assemblies containing illumination should only be used with the light wavelength range of 425nm to 700nm.
Device Description
The Katalyst Revolver Laser Probes are cables made out of one fiber optic (Single-Use), one laser adapter(Reusable), and one handle (Reusable) for surgeon manipulation, metal tubing extending from the handle which penetrates into the surgical site and protective sheath over the fiber.
The fiber for laser transmission is made out of glass, and is restricted for use within the wavelength range of 500nm to 900nm.
The fiber for illumination transmission is made out of either glass or plastic.
The illumination fiber (glass or plastic) is between 100 and 750 microns in size (measure based on the core diameter). The laser fiber (glass) is between 150 and 300 microns in size (measure based on the core diameter).
The tubing is provided in four different variations are referred to as straight, Curved, Flex-Curved, Steerable and Articulating. The configuration is chosen based on the surgeon requirements. The total length of the device is 8-10 feet.
In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1-2 feet, while both branches run for the remainder of the 8-10 feet with each branch having its own protective sheath and each branch ending with its own adapter. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.
The Revolver Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm. The Revolver Illumination Probes can only be used with the light wavelength range of 425nm to 700nm.
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K Number
K123172Device Name
KOGENT BIPOLAR FORCEPS
Manufacturer
KATALYST SURGICAL, LLC
Date Cleared
2012-12-21
(73 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
KATALYST SURGICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kogent Disposable Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.
Device Description
This device is a disposable bipolar forceps, designed for single use in electrosurgical procedures. They require connection with a suitable bipolar cable to the bipolar output of an electrosurgical generator. These forceps are designed to grasp, manipulate, coagulate, and irrigate, when applicable, selected tissues. The irrigation tube is designed to carry fluid to the tips of the instrument. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The devices are provided sterile by ethylene oxide and in sterile packs.
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K Number
K121187Device Name
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
Manufacturer
KATALYST SURGICAL, LLC
Date Cleared
2012-09-17
(151 days)
Product Code
HQF, HQB, MPA
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
KATALYST SURGICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelength of 500nm to 900nm.
Device Description
The laser probes are cables made out of one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates into the surgical site, and protective sheath over the fiber.
The illuminated laser probes (referred to also as "laser/illumination probes") are cables made out of two fiberoptics (one for laser and one for illumination), one laser connector, one illumination connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle, and protective sheath over both fiberoptics.
On one side, the distal side, the fiberoptic is terminated by a connector that attaches to the machine, be it laser or illumination. On the other side, it is terminated by a stainless steel tubing which penetrates into the eye, and may be 20g, 23g, or 25g in size in case of laser probes, or 20g in case of laser/illumination probes.
The fiber for laser transmission is made out of glass, and is restricted for use within the wavelength range of 500nm to 900nm. The fiber for illumination is made out of either glass or plastic. The tubing is provided in two shapes, referred to as straight or curved. The configuration is chosen based on the surgeon requirements. The total length of the device is 10 feet.
In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1 foot, while both branches run for 9 feet with each branch having its own protective sheath and each branch ending with its own connector. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.
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