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510(k) Data Aggregation
K Number
K201160Device Name
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
Manufacturer
M.I. Tech Co., Ltd
Date Cleared
2021-07-23
(449 days)
Product Code
ESW
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
M.I. Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Device Description
This self-expanding tubular prosthesis is designed to maintain patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and an over the wire (OTW) delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers made of gold wire, fully or partially covered silicone membrane, and one repositioning lasso at each end of the stent made of polymeric materials. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The HANAROSTENT® Esophagus (CCC) and the HANAROSTENT® Esophagus (NCN) are intended for single use only.
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K Number
K201342Device Name
HANAROSTENT Trachea/Bronchium (CCC)
Manufacturer
M.I. Tech Co., Ltd.
Date Cleared
2020-12-31
(225 days)
Product Code
JCT
Regulation Number
878.3720Why did this record match?
Applicant Name (Manufacturer) :
M.I. Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT® TracheaBronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
Device Description
The HANAROSTENT® Trachea/Bronchium (CCC) is a self-expanding tubular prosthesis designed to maintain patency of tracheal or/and bronchial obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titaniumalloy (nitinol) wire that is fully covered with a silicone membrane and has one repositioning lasso at one end of the stent. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device and expanded in the body by pulling the outer sheath of the delivery device. The stent and delivery device are provided sterile and are intended for single use only.
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K Number
K200860Device Name
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
Manufacturer
M.I. Tech Co., Ltd
Date Cleared
2020-05-20
(49 days)
Product Code
ESW
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
M.I. Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Device Description
This self-expanding tubular prosthesis is designed to maintain esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and a through-the scope delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers made of gold wire, fully or partially covered silicone membrane, and repositioning lasso made of polyester. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The delivery system is compatible with a minimum 3.7mm working channel of a therapeutic endoscope. The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (NCN) are intended for single use only.
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K Number
K183616Device Name
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
Manufacturer
M.I. Tech Co., Ltd.
Date Cleared
2019-01-10
(15 days)
Product Code
MQR, MUM
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
M.I. Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in palignant structures.
The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
Device Description
This self-expanding tubular prosthesis designed to maintain patency of colorectal or duodenal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) are intended for single use only.
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K Number
K180180Device Name
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
Manufacturer
M.I. Tech Co., Ltd.
Date Cleared
2018-11-02
(283 days)
Product Code
MQR, MUM
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
M.I. Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant structures.
The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
Device Description
This self-expanding tubular prosthesis is designed to maintain patency of colorectal or duodenal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAxTM Duodenum/Pylorus (NNN) are intended for single use only.
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K Number
K111149Device Name
HANAROSTENT BILIARY (NNN)
Manufacturer
M.I. TECH CO., LTD.
Date Cleared
2011-12-30
(249 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
M.I. TECH CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT® BILIARY (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
Device Description
The HANAROSTENT® Biliary (NNN) is a self-expanding uncoated tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors. It consists of a self-expanding metal stent and delivery system. The Biliary stent is made of Nickel Titanium alloy (Nitinol) wire, which expands at body temperature. The stent is deployed with supplied introducers for percutaneous and endoscopic use.
The Stent is available in two diameters (8 and 10mm) and eight lengths (40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, and 120mm). User preference, individual patient condition and/or anatomy determine the appropriate type and size for use. The HANAROSTENT® Biliary (NNN) is intended for single use only.
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K Number
K093537Device Name
HANAROSTENT ESOPHAGUS (CCC)
Manufacturer
M.I. TECH CO., LTD.
Date Cleared
2010-06-04
(200 days)
Product Code
ESW, CLA
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
M.I. TECH CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HANAROSTENT® Esophagus (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
Device Description
HANAROSTENT® Esophagus (CCC) is a self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of esophageal strictures caused by malionant tumors. The stent is made of Nitinol wire (hook and cross wire structure) and a silicon membrane designed in such a way as to prevent migration and tumor in-growth. The stent is symmetrical in shape, with the diameter of both ends of the stent extending beyond the diameter of the stent body (larger banded flanges). This band design has become standard practice and aids in preventing stent migration.
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K Number
K072094Device Name
CHOOSTENT
Manufacturer
M.I. TECH CO., LTD.
Date Cleared
2008-09-25
(423 days)
Product Code
ESW
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
M.I. TECH CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CHOOSTENT™ covered esophageal stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula.
Device Description
This stent is a self-expanding tubular prosthesis designed to maintain patency of esophageal stricture caused by malignant tumors. The unique structure of the membrane connects the several segments to increase the flexibility of the stent and to prevent migration and tumor in-growth. Since the both ends of stent have larger bands, the stent can be fixed firmly within the esophagus. There are totally 12 excellent radiopaque markers made of gold wires; 4 each on both ends of the stents and another 4 at the center. Two retrieval lassos attached to the both ends play a role in removing the stent when necessary or pulling the stent up to the right position in case the stent has been deployed deeply down the stricture. The fully expanded diameter is 18mm for the body and 24mm for both larger bands. There are four standard lengths: 80mm, 110mm, 140mm, 170mm.
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