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Found 6 results
510(k) Data Aggregation
K Number
K250663Device Name
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
Manufacturer
Taewoong Medical Co., Ltd.
Date Cleared
2025-03-31
(26 days)
Product Code
MUM, MQR
Regulation Number
878.3610Why did this record match?
Product Code :
MUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
Niti-S Colonic Comfort Stent 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 strictures.
Device Description
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of an implantable metallic stent and an introducer system.
The stent is made of nitinol wire and is designed as a flexible, fine mesh tubular prosthesis with several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm, while the Niti-S Colonic Comfort Stent is available in diameters of 22 mm and 24 mm. Both stent types are available in lengths of 60 mm, 80 mm, 100 mm, and 120 mm.
The stent delivery system accommodates a 0.035 in (0.89 mm) guidewire. It is advanced over the guidewire and passed through an endoscope into the duodenum or colon. Fluoroscopy is recommended to ensure accurate device placement.
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K Number
K223067Device Name
Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
Manufacturer
Taewoong Medical Co., Ltd.
Date Cleared
2023-06-14
(264 days)
Product Code
MUM
Regulation Number
878.3610Why did this record match?
Product Code :
MUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
The Niti-S Colonic Comfort Stent is indicative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Device Description
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of the implantable metallic stent and introducer system.
The stent is made of nitinol wire. It is a flexible, fine mesh tubular prosthesis that has several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm while the Niti-S Colonic Comfort Stent has diameters of 22 and 24 mm. They both have lengths of 60, 80, 100, and 120 mm.
The introducer system accepts a 0.035 in (0.89 mm) guidewire. The introducer system is passed over the guidewire and through an endoscope into the duodenum or colon. Use of fluoroscopy is recommended to ensure correct placement of the device.
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K Number
K163468Device Name
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
Manufacturer
Cook Ireland Ltd.
Date Cleared
2017-05-04
(143 days)
Product Code
MUM, MQR
Regulation Number
878.3610Why did this record match?
Product Code :
MUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Evolution® Duodenal Stent System- Uncovered: This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.
Evolution® Colonic Stent System- Uncovered: This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Device Description
This flexible, self-expanding stent is constructed of nitinol wire. The stent diameter is increased at either end to help provide resistance to migration. The total length of the stent is indicated by radiopaque markers on the inner catheter. indicating the actual length of the stent at the nominal stent diameter.
Introduction System Description:
The stent is mounted on an inner catheter, which accepts a 0.035 inch wire guide and is constrained by an outer catheter. The handle allows for desheathing to deploy the stent and resheathing to recapture the stent during stent deployment.
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K Number
K101530Device Name
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
Manufacturer
COOK IRELAND LTD
Date Cleared
2011-03-29
(299 days)
Product Code
MUM
Regulation Number
878.3610Why did this record match?
Product Code :
MUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.
Device Description
Stent Description: This flexible, self-expanding stent is constructed of nitinol wire. The total length of the stent is indicated by radiopaque markers on the inner catheter, indicating the actual length of the stent at nominal stent diameter. The stent has flanges at both stent ends.
Introducer System Description: The stent is mounted on an inner catheter, which accepts a 0.035 inch wire guide and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or recapture.
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K Number
K062750Device Name
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
2006-12-04
(81 days)
Product Code
MUM
Regulation Number
878.3610Why did this record match?
Product Code :
MUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.
Device Description
The proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is manufactured of Nitinol and has a 22mm body diameter with a 27mm distal flare diameter, and is offered in three lengths, 6cm, 9cm, and 12cm. The Anchor Lock Delivery System consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.
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K Number
K980113Device Name
WALLSTENT ENTERAL ENDOPROSTHESIS
Manufacturer
BOSTON SCIENTIFIC SCIMED, INC.
Date Cleared
1998-04-03
(80 days)
Product Code
MUM
Regulation Number
878.3610Why did this record match?
Product Code :
MUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Schneider (USA) Inc Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.
Device Description
The WALLSTENT® Enteral Endoprosthesis is comprised of two components: the temporary (short-term) implantable metallic stent and the delivery device. The stent is composed of implant-grade cobalt-base superalloy wire braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant and The stent is available in multiple sizes. Physician preference and self-expanding. individual patient condition and/or anatomy will determine the appropriate size chosen.
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