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510(k) Data Aggregation
K Number
K241956Device Name
Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
Manufacturer
Hunan Endoso Life Technology Co., Ltd.
Date Cleared
2025-01-22
(203 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hunan Endoso Life Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a disposable medical device, the product is used along with the company's image processor, to enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation to the patient's ureter and renal pelvis.
Device Description
The Single-Use Digital Flexible Ureteroscope (Model: PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) is an endoscope which is used with the Monitor for Single-Use Endoscopy (Model:P1-D) produced by ENDOSO LIFE TECHNOLOGY for providing endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment. The Single-Use Digital Flexible Ureteroscope is integrated with a working channel which allowing the use of flexible endoscopic accessories (e.g. stone basket, forceps, laser fibers for lithotripsy, etc.). The insertion portion of the endoscope is flexible, and the shape changes corresponding to the shape of the cavity. Anatomical images are captured by a CMOS chip at the distal end of the endoscope and the electronic signals are transmitted to the Monitor. Then, the resulting picture images are sent to and shown on a visual display.
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K Number
K231107Device Name
Bronchoscope System
Manufacturer
Hunan Endoso Life Technology Co., Ltd.
Date Cleared
2024-02-15
(302 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Hunan Endoso Life Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment.
The Single-use Bronchoscope is a disposable device designed for use in adults.
Device Description
The Bronchoscope System consists of Single-use Bronchoscope (Model: BC12-1, BC12-2, BC20-1, BC20-2, BC22-1, BC22-2, BC22-3, BC28-1, BC28-2, BC28-3) to be introduced within the airways or tracheobronchial tree and Monitor for Single-Use Endoscopy (Model: P1-A, P1-C, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E) for clinical image processing. The Single-use Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Monitor provides power and processes the images for medical electronic endoscope.
The Single-use Bronchoscope is a sterile single use flexible bronchoscope. The Monitor for Single-Use Endoscopy is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the disposable video Bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Monitor for Single-Use Endoscopy via the VI circuit. The Monitor receives video signals from the endoscope, processes the video signals and outputs the processed video signal. The Monitor also controls the brightness of the LEDs on the endoscope.
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K Number
K231725Device Name
Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
Manufacturer
Hunan Endoso Life Technology Co., Ltd.
Date Cleared
2023-10-16
(125 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hunan Endoso Life Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is used in medical institutions for observation and imaging in abdominal surgery by entering the human body through the wound.
Device Description
The Laparoscope (Model: 4KA0、4KA0R、4KA30、4KA30R、4KA45、4KA45R) is used in medical institutions. Laparoscopes are tubular optical instruments used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The Laparoscope transmits light in both the visible and near infrared spectrum to illuminate and image the anatomy, then forms and relays the image of the surgical site to a camera system for processing and display.
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