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510(k) Data Aggregation
K Number
K220872Device Name
Saberscope5 Laparoscope
Manufacturer
Date Cleared
2022-04-20
(26 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Xenocor, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SaberScope5 Laparoscope is intended to be used in diagnostic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.
Device Description
The Articulating Xenoscope™ System is being renamed the SaberScope5 Laparoscope. The subject device contains two separate functioning components. First is the single-use, sterile SaberScope5 Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 90° articulating tip, 10 - 36 cm long shaft, and high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. The second is the XenoBox™, 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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K Number
K193315Device Name
Xenocor Articulating Xenoscope Laparoscope
Manufacturer
Date Cleared
2020-01-27
(59 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Xenocor, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Articulating Xenoscope 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.
Device Description
The Articulating Xenoscope™ System contains two separate functioning components. First is the single-use, sterile Articulating Xenoscope™ Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 30° articulating tip, 10 cm or 36 cm long shaft, and high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. The second is the XenoBox™, which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view. Together, the Xenoscope™ and the Xenobox™ comprise the Xenoscope™ Laparoscopic System and work synergistically together.
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K Number
K171344Device Name
Xenocor Xenoscope Laparoscopic System
Manufacturer
Date Cleared
2017-06-01
(24 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Xenocor, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Xenoscope™ 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.
Device Description
The Xenoscope™ System contains two separate functioning components. First, the Xenoscope™ Laparoscope Device is a 0° or 30°, 30 Fr (10mm), 10 - 36 cm long, singleuse, high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. Second, the Xenoscope™ Dongle (now termed as the Xenobox™), which converts the camera image onto the video display screen for the surgeon to use, is provided with the Xenoscope™. Together, the Xenoscope™ and the Xenobox™ comprise the Xenoscope™ Laparoscopic System and work synergistically together.
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K Number
K161838Device Name
Xenocor Xenoscope Laparoscopic System
Manufacturer
Date Cleared
2016-09-26
(83 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Xenocor, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Xenoscope™ 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.
Device Description
The Xenoscope™ System contains two separate functioning components. First, the Xenoscope™ Laparoscope Device is a 0°, 30 Fr (10mm), 10 - 36 cm long, single-use, high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. Second, the Xenoscope™ Dongle, which converts the camera image onto the video display screen for the surgeon to use, is provided with the Xenoscope™. Together, the Xenoscope™ and the Xenoscope™ Dongle comprise the Xenoscope™ Laparoscopic System and work synergistically together.
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