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510(k) Data Aggregation
K Number
K180650Device Name
Amsel Endo Occluder
Manufacturer
Date Cleared
2018-11-15
(247 days)
Product Code
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Amsel Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Amsel Endo Occluder device is an endoscopic ligating clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
Device Description
Amsel Endo Occluder device is an endoscopic ligating clip applier that is pre-loaded with four sterile ligating clips. Amsel Endo Occluder device is intended to be used during endoscopic procedures (such as Laparoscopic procedures), for permanent secure occlusion of blood vessels and ductal structures. The device is a mechanical occlusion clip that when deployed transfixes the target vessel while clamping it shut. Amsel Endo Occluder contains two main components: Ligating (Occluder) Clips and Applier (device delivery).
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K Number
K140932Device Name
AMSEL OCCLUDER DEVICE
Manufacturer
Date Cleared
2015-01-23
(287 days)
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
AMSEL MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
Device Description
The Amsel Occluder Device involves the implantation of a mechanical occlusion device that penetrates into and through the target vessel structure and when compressed and locked, clamps the vessel shut.
The device consists of a metallic clip construct comprised of two compression components and an interlocking implant rod that when compressed together as a unit and locked on either side of a vessel results in occlusion. The delivery device consists of a hand held syringe-like device loaded with the components of the implant construct. The device is for use in general surgical procedures. Once positioned correctly, the occlusion construct is actuated through a series of semiautomatic steps resulting in the two components becoming compressed on either side of the vessel and locked together to occlude the vessel. Once occlusion is achieved, the delivery system, which is mechanically locked to the implant rod, is detached from the implant and the needle is withdrawn leaving the occlusion construct implanted, permanently occluding the vessel.
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