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510(k) Data Aggregation
K Number
K250695Device Name
Single-use Ureteral Access Sheath
Manufacturer
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Date Cleared
2025-07-08
(123 days)
Product Code
FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen HugeMed Medical Technical Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K241444Device Name
Biliary Pancreaticobiliary Scope System
Manufacturer
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Date Cleared
2025-01-21
(244 days)
Product Code
FBN, FET, KQM, NTN
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen HugeMed Medical Technical Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biliary Pancreaticobiliary Scope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope and the Image Processor. The Single-use Biliary Pancreaticobiliary Scope is intended to provide direct visualization, illumination and to guide accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Image Processor is intended to receive, process, and output images from the Single-use Biliary Pancreaticobiliary Scope for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
Device Description
The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope (model:CL-A, CL- B), and the Image Processor (model: HUV-02). The Single-use Biliary Pancreaticobiliary Scope is a flexible scope, introduced into the pancreatico-biliary system via a duodenoscope. The Single-use Biliary Pancreaticobiliary Scope comprises a handle, an insertion tube, and a connection cable.
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K Number
K240374Device Name
Ureterorenoscope System
Manufacturer
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Date Cleared
2024-05-10
(93 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen HugeMed Medical Technical Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ureterorenoscope System has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.
Device Description
The Ureterorenoscope System consists of a single-use Ureterorenoscope(HU30S) to provide illumination and intuitive images in endoscopy and endoscopic surgery within urinary tract and interior of the kidney and serves as a guide to diagnosis and management with accessories and an image processor, previous clearly by K231118, for clinical image processing.
The single-use Ureterorenoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Ureterorenoscope and outputs video signals to a display.
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K Number
K232435Device Name
Rhinolaryngoscope system
Manufacturer
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Date Cleared
2024-04-26
(256 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen HugeMed Medical Technical Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via an Image Processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.
Device Description
The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) to be introduced within the nasal lumens and upper airway anatomy and Image Processor (model: VLM-02) for clinical image processing. The Image Processor provides power and processes the images for medical electronic endoscope. The Single-Use Rhinolaryngoscope is a sterile single used flexible Rhinolaryngoscope. The Image Processor is a reusable monitor.
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K Number
K231118Device Name
Cystoscope System
Manufacturer
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Date Cleared
2023-11-13
(207 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen HugeMed Medical Technical Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The single-use cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The single-use is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.
Device Description
The Cystoscope System consists of a single-use Cystoscope to provide illumination and intuitive images in endoscopic surgery of the lower urinary tract and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing. The single-use Cystoscope is a sterile single-use flexible Cystoscope. The image processor is a reusable monitor. The single-use Cystoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Cystoscope and outputs video signals to a display.
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