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510(k) Data Aggregation
K Number
K232295Device Name
LAA Exclusion System
Manufacturer
Syntheon, LLC
Date Cleared
2023-08-30
(29 days)
Product Code
PZX
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Syntheon, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
Device Description
The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm, 40mm, 45mm to accommodate different sizes of LAA. The LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.
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K Number
K220305Device Name
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
Manufacturer
Syntheon
Date Cleared
2022-10-28
(268 days)
Product Code
PZX
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Syntheon
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
Device Description
The Syntheon LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm. 40mm, 45mm, and 50mm to accommodate different sizes of LAA. The Syntheon LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.
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K Number
K080317Device Name
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
Manufacturer
SYNTHEON LLC
Date Cleared
2008-04-29
(83 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SYNTHEON LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoLok™ is indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy.
Device Description
The EndoLok™ is a non-sterile, single-use device designed to be used in conjunction with standard colonoscopes. It consists of a handle with a trigger mechanism that is used to grip the colonoscope shaft.
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