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510(k) Data Aggregation
K Number
K080780Device Name
ANCHORAGE SCOPE, MODEL 000003
Manufacturer
EPITEK, INC.
Date Cleared
2008-07-30
(133 days)
Product Code
FBO, GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
EPITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anchorage™ Scope is a flexible fiber optic endoscope intended for the visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The Anchorage Scope is indicated for the following applications:
Ureteroscopy Bronchoscopy Thoracoscopy Nasopharyngoscopy/Sinuscopy General laparascopy Urology Gynecology
Device Description
The Anchorage™ Scope is a flexible fiber optic endoscope provided as a sterile single use device. The endoscope is used to visualize body cavities, organs, canals, and tissues. The Anchorage Scope is introduced through natural body cavities or surgical incisions through introducers or trocars, catheters, sheaths or other devices of with lumens having an inside diameter greater than the outside diameter of the endoscope.
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K Number
K073507Device Name
ANCHORAGE ACCESS KIT
Manufacturer
EPITEK, INC.
Date Cleared
2008-03-05
(83 days)
Product Code
ODC, KOG
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
EPITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anchorage™ Access Kit facilitates percutaneous access in order to establish a guide through which surgical instruments or devices can be intubated.
Device Description
The Anchorage Access Kit is a system of components used to gain percutaneous access and provide a conduit for the Anchorage Closure Device (K073096) or other surgical instruments.
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K Number
K073096Device Name
ANCHORAGE CLOSURE DEVICE
Manufacturer
EPITEK, INC.
Date Cleared
2008-02-07
(98 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
EPITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anchorage™ Closure Device facilitates placement of a pre-tied ligature for use in surgical applications where soft tissue must be approximated and/or ligated.
Device Description
The Anchorage Closure Device is a one piece, single-use system comprised of components used to deliver and deploy a pre-tied suture in order to achieve soft tissue approximation and/or ligation.
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