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510(k) Data Aggregation
K Number
K230004Device Name
Disposable Hemoclip
Manufacturer
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Date Cleared
2023-07-31
(209 days)
Product Code
PKL
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Hemoclip is indicated for endoscopic clip placement within the gastrointestinal 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. Anchoring to affix jejunal feeding tubes to the wall of the small bowel
4. As a supplementary method, closure for GI tract luminal perforations <20mm that can be treated conservatively.
Device Description
The Disposable Hemoclip consists of one pre-loaded clip and delivery system for single patient use only. Disposable Hemoclip is provided in sterile. The clip is made of stainless steel with good superelasticity performance. The clip is pre-loaded in end of the Spring tube part through its deformation and it is deployed from the delivery system during use.The clip is engineered such that they can be opened and closed up to many times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. The delivery system consists of a handle and delivery catheter. The delivery system will allow for the device to rotate at the distal end.
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K Number
K222980Device Name
Pentax Medical Valve Set
Manufacturer
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Date Cleared
2022-11-21
(54 days)
Product Code
ODC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials.
- Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
- Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
- Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
- Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Device Description
The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
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K Number
K220785Device Name
Clean Connecting Tube
Manufacturer
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Date Cleared
2022-09-27
(194 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clean Connecting Tube (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air(via an air pump) or CO2(Via a CO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction pump or electrosurgical unit.
Device Description
The Clean Connecting Tube is intended for 24 hour multiple-patient use and then discarded. The Clean Connecting Tube design minimizes infection control risks that are associated with manual cleaning and sterilization.The maximum number of patient is up to 15 in 24 hours , and maximum duration of us shall not exceed 15h. The check valve attached to the irrigation tubing shall be replaced after every patient use. The Clean Connecting Tube is manufactured for use in conjunction with sterile water bottle, and together with irrigation pump. The Clean Connecting Tube is designed to be attached to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.
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K Number
K220292Device Name
Disposable Endoscope Injection Needle
Manufacturer
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Date Cleared
2022-08-19
(199 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Endoscope Injection Needle is used for endoscopic injection into gastrointestinal mucosa and submucosa to:
• introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system;
• aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures;
• control non-variceal hemorrhage.
Device Description
The Disposable Endoscope Injection Needle consists of Sheath, Handle buckle, Handle, Booster tube, Handle end cap, Outer tube, Inner tube, Metal end cap and injection needle tip. It is available in a variety of configurations with varying needle lengths, gauges and working lengths.
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K Number
K220790Device Name
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
Manufacturer
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Date Cleared
2022-06-27
(102 days)
Product Code
FDI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.
Device Description
The Disposable Polypectomy Snare is available in two different types with rotating snare and non-rotating snare. The cutting wire diameter of the snares is 0.4mm. The catheter diameters are 1.8mm and 2.4mm the depending on the version. The snares are available in different forms, lengths and openings depending on the type.
- Non-rotating snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm, 25mm,30mm, 35mm. Working lengths 1800mm and 2300mm.
- Rotatable snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm.25mm. 30mm. 35mm. Working lengths 1800mm and 2300mm.
The Disposable Polypectomy Hybrid Snare is available in two different types with rotating snare and non-rotating snare. Only one available loop shape is Hybrid. The cutting wire diameter of the snares is 0.4mm. The catheter diameters is 2.4mm. The snares are available in different forms, lengths and openings depending on the type.
- Non-rotating snares: available in the opening widths 10mm, 15mm. Working lengths 1800mm and 2300mm.
- Rotatable snares: available 10mm, 15mm. Working lengths 1800mm and 2300mm.
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K Number
K220210Device Name
Disposable Endoscopy Adapter Set
Manufacturer
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Date Cleared
2022-06-17
(142 days)
Product Code
ODC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Endoscopy Adapter Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.
- Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
- Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
- Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
- Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Device Description
The Disposable Endoscopy Adapter Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
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