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Found 7 results
510(k) Data Aggregation
K Number
K200902Device Name
ClickClean
Manufacturer
Medeon Biodesign, Inc.
Date Cleared
2020-04-30
(27 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Medeon Biodesign, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
Device Description
The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
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K Number
K193652Device Name
AbClose - Port Site Closure Device
Manufacturer
Medeon Biodesign, Inc.
Date Cleared
2020-03-26
(87 days)
Product Code
OCW, GCJ, HCF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Medeon Biodesign, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Device Description
The AbClose™ - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques.
The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by folding the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.
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K Number
K192891Device Name
Laparoscope Lens Shield Device (LENS)
Manufacturer
Medeon Biodesign, Inc
Date Cleared
2019-11-07
(28 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Medeon Biodesign, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
Device Description
The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
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K Number
K170103Device Name
Laparoscope Lens Shield Device (LENS)
Manufacturer
Medeon Biodesign, Inc
Date Cleared
2017-02-16
(35 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Medeon Biodesign, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
Device Description
The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
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K Number
K160117Device Name
AbClose - Port Site Closure Device
Manufacturer
Medeon Biodesign, Inc
Date Cleared
2016-09-09
(234 days)
Product Code
OCW, GCJ, HCF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Medeon Biodesign, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Device Description
The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures. facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.
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K Number
K160172Device Name
Laparoscope Lens Shield Device
Manufacturer
Medeon Biodesign, Inc
Date Cleared
2016-04-21
(85 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Medeon Biodesign, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
Device Description
The Laparoscope Lens Shield Device (LENS) is a laparoscope accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
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K Number
K151117Device Name
Laparoscope Lens Shield Device
Manufacturer
Medeon Biodesign, Inc
Date Cleared
2015-08-20
(115 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Medeon Biodesign, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
Device Description
The Laparoscope Lens Shield Device (LENS) is a laparoscope accessory lens shielding device consisted of multi-lumen sheath that slides over the laparoscope. The sheaths assembly consists of 3 concentric sheaths: one outer and two inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids The Laparoscope Lens Shield Device (LENS) is intended to be used by clinicians through prescription use only.
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