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510(k) Data Aggregation
K Number
K061831Device Name
MEDCHANNEL HTS SYSTEM
Manufacturer
MEDCHANNEL, LLC
Date Cleared
2006-08-07
(40 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
MEDCHANNEL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HTS System is an adjunctive audio vessel landmarking aid for use during hemorrhoidal artery treatment. It is not recommended for fetal or ophthalmic use.
Device Description
The HTS System is an adjunctive audio vessel landmarking aid for use during hemorrhoidal artery treatment. It is not recommended for fetal or ophthalmic use. Doppler audio sounds are heard when the transducer is positioned directly over a hemorrhoidal artery. Cessation of Doppler sounds occurs when ligation of the identified vessel has been completed successfully. Acoustic output values for this transducer are lower than the maximum pre-amendment intensities specified for "Peripheral Vessel" and "Fetal Imaging and Other" applications. There is only one transducer available with this system. The System includes disposable/single use accessories which can be used to perform the manual ligation of the hemorrhoidal arteries.
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K Number
K060494Device Name
EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
Manufacturer
MEDCHANNEL, LLC
Date Cleared
2006-07-03
(129 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
MEDCHANNEL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EasyTac Anchor and delivery system is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.
Device Description
The EasyTac Anchor device is an endoscopic or open surgical stapler composed of a disposable delivery instrument and resorbable fixation devices. The EasyTac Anchor Delivery System consists of an ergonomic handle, trigger, locking and unlocking mechanism, totation knob, shaft containing a cartridge of five to fifteen fixation devices, and retractable hollow needle.
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K Number
K051700Device Name
OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR
Manufacturer
MEDCHANNEL, LLC
Date Cleared
2005-08-15
(52 days)
Product Code
GAM, FEB
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
MEDCHANNEL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OptiCLEAN Lens Irrigator is a disposable device to be used in combination with a 10 mm diameter scope to prevent dimming and fogging of the lens.
The OptiDOCK Tissue Ligator is a disposable device intended to pass an absorbable suture loop during endoscopic procedures.
Device Description
The MedChannel OptiCLEAN Lens Irrigator is a single lumen endoscopic lens irrigator, designed for attachment to 10 mm diameter endoscopes. The irrigator comes in two sizes 285 mm or 305 mm, depending on surgeon's preference. The lens irrigator provides irrigation to the lens of an endoscope to prevent dimming and fogging of the lens during endoscopic surgical procedures.
The MedChannel OptiDOCK Tissue Ligator is a single use disposable suture passer, designed for use during endoscopic procedures. The OptiDOCK Tissue Ligator is pre loaded with PGA suture (USP 2-0).
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