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510(k) Data Aggregation
K Number
K243039Device Name
Ureteral Stents (AF-D series)
Manufacturer
Alton (Shanghai) Medical Instruments Co. Ltd
Date Cleared
2025-06-18
(264 days)
Product Code
FAD
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
Alton (Shanghai) Medical Instruments Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ureteral Stents (AF-D series) are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral Stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques. The indwelling time should not exceed 30 days.
Device Description
Ureteral Stents (AF-D series) are a set of ureteral stents used for temporary internal drainage from the ureteropelvic junction to the bladder. The subject ureteral stent is a flexible, tubular double pigtail stent composed of thermoplastic polyurethane with hydrophilic coating. Depending on configurations, the device may include a ureteral stent only, or a stent with an introducer and a clamp, or a stent with an introducer, a guidewire and a clamp.
Ureteral Stents are available in 4.0 to 7.0 French (Fr) diameter, with lengths ranging from 8.0 to 28.0 centimeters (cm). The device is supplied sterile, intended for single use only, and is available for prescription use only.
Ureteral Stents are not intended as a permanent indwelling device. The subject stent is labeled for indwell time not to exceed thirty (30) days only.
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K Number
K242635Device Name
Endoscopic Distal Attachment (AF-D series)
Manufacturer
Alton (Shanghai) Medical Instruments Co. Ltd
Date Cleared
2025-05-30
(269 days)
Product Code
FDS, FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Alton (Shanghai) Medical Instruments Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoscopic Distal Attachment is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Device Description
The Endoscopic Distal Attachment is an additional device, made of TPU designed to attach to the distal end of the endoscope. The device is composed of three main portions: an attaching portion, a distal portion, and a drain portion. The attaching portion is a wider diameter opening which is used to connect the attachment to a compatible endoscope; the distal portion is the ending portion of the attachment which tapers into narrower diameter opening. The hole, which is only available for some models, forms drain portion which prevent the fluids lodging on the surface of the endoscope.
The Endoscopic Distal Attachment can be used in combination with compatible endoscopes to maintain an appropriate endoscopic field of view.
The Endoscopic Distal Attachment has six models, depending on different surface design (flat or incline), with or without hole and with scale or without scale. The models include models of flat face without hole, flat face with hole, inclined face without hole, inclined face with hole, flat face without hole with scale and flat face.
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K Number
K241679Device Name
Disposable Cytology Brush (AF series)
Manufacturer
Alton (Shanghai) Medical Instruments Co. Ltd
Date Cleared
2025-03-04
(266 days)
Product Code
KTI, BTG
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Alton (Shanghai) Medical Instruments Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.
Intended patient population: Adults
Device Description
The Disposable Cytology Brush is a sterile, single-use device as a kind of accessories for bronchial endoscopy. The Disposable Cytology Brush is intended to be used in conjunction with a bronchoscope to collect cells from the bronchi.
The Disposable Cytology Brush is designed to insert through suitable endoscope's accessory channel to collect cells from the bronchi.
The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/ pull rod.
The Disposable Cytology Brush has two different models depending on different design of the brush head. The WB series is a cytology brush with straight type of brush head and the XA series is a cytology brush with oval type of brush head. Each model has different specifications depending on different working length.
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K Number
K241285Device Name
Disposable Endoscope Valves Set (AF series)
Manufacturer
Alton (Shanghai) Medical Instruments Co. Ltd
Date Cleared
2024-10-01
(147 days)
Product Code
ODC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Alton (Shanghai) Medical Instruments Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Endoscope Valve Sets 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. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.
- 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.
- 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.
- 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.
- Auxiliary Water Connector: 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 Endoscope Valves Set is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.
- The Suction Valve component of the Disposable Endoscope Valves Set is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.
- The Air/Water Valve component of the Disposable Endoscope Valves Set is designed to be attached to the air/ water port of the endoscope, the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
- The Biopsy Valve component of the Disposable Endoscope Valves Set is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
- The Auxiliary Water Connector component of the Disposable Endoscope Valves Set is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle.
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K Number
K231633Device Name
Disposable Hemoclip (AF series)
Manufacturer
Alton (Shanghai) Medical Instruments Co. Ltd
Date Cleared
2024-01-11
(220 days)
Product Code
PKL
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Alton (Shanghai) Medical Instruments Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable 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 < 3 cm
• Bleeding ulcers
• Arteries < 2 mm
• Polyps < 1.5 cm in diameter
• Diverticula in the colon
3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel;
4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively.
Device Description
The Disposable Hemoclip is the key and common accessory in the diagnosis and treatment procedure of digestive endoscope. As a single use instrument, the disposable hemoclip does not allow to be used by twice, and cannot be separated by components except to be used as well. It is also a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and tube. The delivery system is constructed using stainless steel and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1600mm, 1800mm, 2100mm and 2300mm working lengths.
The clip is made of stainless-steel material and deployed from the delivery system during use. The clip jaws are designed that they can be opened and closed up to five 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.
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K Number
K230925Device Name
Disposable Injection Needle AF series
Manufacturer
Alton (Shanghai) Medical Instruments Co. Ltd
Date Cleared
2023-09-27
(177 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Alton (Shanghai) Medical Instruments Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Injection Needle is intended 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.
Device Description
The Disposable Injection Needle is a sterile, single-use device as a kind of accessories for digestive endoscopy. The Disposable Injection Needle is intended 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 Disposable Injection Needle is designed to insert through the suitable endoscope's forceps to inject harden agent to target lesion in treatment for bleeding of esopha-gastric varix or to mark the lesions of the digestive tract.
The Disposable Injection Needle has different model specifications depending on different working length and the needle size.
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