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510(k) Data Aggregation
K Number
K212999Device Name
Multi-Functional Electrosurgical Knife
Manufacturer
Anrei Medical (Hangzhou) Co., Ltd.
Date Cleared
2022-03-21
(182 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Anrei Medical (Hangzhou) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single Use Electrosurgical Knife has been designed to be used with flexible endoscopes to cut tissue using highfrequency current within the digestive tract.
Device Description
The device is an endoscopic electrosurgical knife for Endoscopic Submucosal Dissection (ESD). The Single Use Electrosurgical Knife is used with flexible endoscopes to cut tissue using high-frequency current within the digestive tract.
It is recommended to use an ERBE VIO-200s electrosurgical unit to supply power to the device.
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K Number
K210917Device Name
Single Use Injection Needle
Manufacturer
Anrei Medical (Hangzhou) Co., Ltd.
Date Cleared
2021-05-28
(60 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Anrei Medical (Hangzhou) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
Device Description
The Single Use Injection Needles are sterile, single-use devices. The Single Use Injection Needles can is expected to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract. The Single Use Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1800mm, 2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.
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K Number
K210660Device Name
Stone Retrieval Balloon Catheter
Manufacturer
Anrei Medical (Hangzhou) Co., Ltd.
Date Cleared
2021-04-27
(54 days)
Product Code
GCA
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
Anrei Medical (Hangzhou) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
Device Description
The Stone Retrieval Balloon Catheter is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some specifications, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some specifications, the balloon can be inflated to three sizes, 8.5mm, 12mm diameters, or 12mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with an outer diameter of 2.3mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end. It is used to insert the guide wire rapidly. EO sterilization and use for single use only.
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K Number
K201771Device Name
Single Use Rotatable and Repositionable Hemoclip
Manufacturer
Anrei Medical (Hangzhou) Co., Ltd.
Date Cleared
2020-10-19
(112 days)
Product Code
PKL
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Anrei Medical (Hangzhou) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking 2) Hemostasis for: Mucosal/sub-mucosal defects < 3cm, Bleeding ulcers. Arteries < 2mm. Polyps < 1.5cm in diameter, Diverticula in the colon, 3) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively
Device Description
The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site.
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K Number
K192048Device Name
Single Use Endoscope Valves Set
Manufacturer
Anrei Medical (Hangzhou) Co., Ltd.
Date Cleared
2020-05-14
(288 days)
Product Code
ODC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Anrei Medical (Hangzhou) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single Use Endoscope Valves Set are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
Device Description
The Single Use Endoscope Valves Set collects three types of valve products into one package unit, and which are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
This is single-use device and supplied sterile.
There are three main components included, which are Air/Water Valve, Suction Valve and Biopsy Valve.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
There are three models for fitting to varied endoscopes as AMH-EV-01; AMH-EV-02; AMH-EV-03. The main differences between models are physical size of components for varied endoscopes interface, but they share same indication for use, materials and components form.
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