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510(k) Data Aggregation
K Number
K240506Device Name
KARL STORZ Holders
Manufacturer
KARL STORZ Endoscopy America, Inc
Date Cleared
2024-10-22
(244 days)
Product Code
OCV, GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ Endoscopy America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.
Device Description
The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
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K Number
K223885Device Name
HOPKINS Telescopes
Manufacturer
Karl Storz Endoscopy America, Inc.
Date Cleared
2023-09-14
(261 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
Karl Storz Endoscopy America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Device Description
The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 12° and 30° direction of view, 2mm, 2.9mm, 4mm diameter and 26cm, 30cm, 36cm working lengths.
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K Number
K230359Device Name
KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-
Manufacturer
KARL STORZ Endoscopy America, Inc
Date Cleared
2023-06-23
(133 days)
Product Code
GCJ, HET
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ Endoscopy America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ suction and irrigation system (consisting of handle and suction/irrigation tubes, cannulae or needles) is intended for use by qualified surgeons to provide suction and/or irrigation function to help flush or remove blood, fluids, and tissue debris from the operation site during general, gynecologic, urologic, and thoracic laparoscopic surgical procedures.
Device Description
The devices in the KARL STORZ Suction and Irrigation System are manually operated, reusable surgical devices consisting of handle, suction/irrigation tubes, cannulae or needles. The handle is intended to be used in combination with suction/irrigation cannulae and tubing and controls the suction and irrigation. Enabled by the handle with stop cock valve, the regulation of the irrigated quantity of fluids via the tubes, or rather the quantity of aspirated fluid (e.g., blood, fluids, and tissue debris) into or out of the patient is performed. Cannula and needle: Enabled by the pointed distal end, both puncture and injection/extraction cannulae and needles, perform puncturing of target organs or tissues and injecting fluids into operating site i.e. extracting blood or fluids from them. The prerequisite for suction is either a vacuum powered suction wall apparatus or a pump, which serve as impulse for the suction. The proximal end of the tube set is connected to the vacuum or pump. Either a pump is required as impulse for irrigation or the natural force of gravity, i.e., by positioning the flush bag at the appropriate height.
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K Number
K221893Device Name
KARL STORZ Bipolar Resectoscopes with HF Cable
Manufacturer
KARL STORZ Endoscopy America, Inc
Date Cleared
2023-03-17
(261 days)
Product Code
FJL, FAS, FDC, GEI, HIH
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ Endoscopy America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic electrosurgical procedures.
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
Indications for Use in UROLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.
Indications for Use in GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic hysteroscopic electrosurgical procedures
Indications for Use in UROLOGY and GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
Device Description
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in medical disciplines such as Urology and Gynecology. A resectoscope is a combined cystoscope (urology) or hysteroscope (gynecology) and electrosurgical instruments and consists of a sheath, obturator, working element and HF electrode.
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K Number
K221004Device Name
HOPKINS Telescopes
Manufacturer
KARL STORZ Endoscopy America, Inc.
Date Cleared
2022-12-20
(259 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ Endoscopy America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.
Device Description
The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 25° and 45° direction of view, 5mm diameter and 29cm working lengths.
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K Number
K222504Device Name
H1
Manufacturer
Karl Storz Endoscopy America, Inc.
Date Cleared
2022-11-10
(84 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Karl Storz Endoscopy America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.
Device Description
The camera head consists of an anodized aluminum, stainless steel enclosure containing a CMOS (Complementary metal-oxide-semiconductor) NTSC image sensor that converts light into electrons, the transistors in each pixel then amplify and move the charge using the more traditional wires forming conventional output signals. The camera head is intended to be attached to the proximal end of the endoscopes and is connected via cable to the compatible CCU for power and operational functions. The camera head is designed to be compatible for use with all standard KARL STORZ Endoscopes, Fiberscopes and Microscope for endoscopic observation in general endoscopic procedures.
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K Number
K213194Device Name
HD Mediastinoscope
Manufacturer
Karl Storz Endoscopy America, Inc.
Date Cleared
2022-06-23
(267 days)
Product Code
EWY
Regulation Number
874.4720Why did this record match?
Applicant Name (Manufacturer) :
Karl Storz Endoscopy America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.
Device Description
The HD Mediastinoscope is a reusable videoendoscope intended to be used in conjunction with the X-link module of the Image1 S Camera Control Unit. The HD Mediastinoscope is comprised of four main components: CMOS sensor at the distal end of the endoscope, an oval insertion portion (spatula), handle, and internal LED light source. The spatula can accommodate up to 2 x 5 mm instruments.
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K Number
K221174Device Name
Telepack +
Manufacturer
KARL STORZ Endoscopy America, Inc
Date Cleared
2022-05-13
(18 days)
Product Code
FET
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ Endoscopy America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TELE PACK + is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.
Device Description
The Telepack + is a portable and compact all-in-one imaging system that includes a 18.5 inch screen display, a camera control unit and internal LED light source, that is intended to be connected to a compatible device (camera head or videoendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack + includes a LED illumination light source to illuminate the intended area and a 18.5 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack + is a non-patient contacting and require only wipe down as needed.
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K Number
K212458Device Name
Flexible Video-Uretero-Renoscope SSU System
Manufacturer
KARL STORZ Endoscopy America
Date Cleared
2022-01-20
(168 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ Endoscopy America
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SSU Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
Device Description
The videoscopes in the modified Flexible Video-Uretero-Renoscope SSU System are sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II, or X-LINK + IMAGE 1S Connect) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.
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K Number
K212656Device Name
Flexible Intubation Video Endoscope Sterile (FIVE-S)
Manufacturer
KARL STORZ Endoscopy America
Date Cleared
2021-12-29
(128 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ Endoscopy America
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexible Intubation Video Endoscope - Sterile (FIVE-S) are intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
Device Description
The Flexible Intubation Video Endoscope - Sterile (FIVE-S) is a sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging sensor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.
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