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510(k) Data Aggregation
K Number
K141097Device Name
CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE
Manufacturer
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD.
Date Cleared
2014-09-26
(151 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CSC Series Intraluminal Stapler for Single Use have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.
The TST Series Tissue-Selecting Therapy Stapler have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Device Description
The proposed device, CSC Series Intraluminal Stapler for Single Use is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. It places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created.
The proposed device, PPHplus Series PPH Stapler and Purse Sets for Single Use is a sterilized and disposable surgical instrument, which has application for general surgical treatment of hemorrhoids. It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The sets are commonly used in the procedures for prolapsed and hemorrhoids. They are also used for other applications when circular or semicircular stapling of anorectic tissue is required.
The proposed device, TST Series Tissue-Selecting Therapy Stapler is a sterilized and disposable surgical instrument, to be used in the surgical treatment of prolapse and hemorrhoids. This device also uses the Stapled Transanal Rectal Resection (STARR) surgical treatment of anorectal wall defects and obstructed defecation syndrome, with a single-fire staple. It is a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is also Used for other applications where circular or semicircular or 1/3 circular stapling of anorectal tissue is desired.
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K Number
K141367Device Name
LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS
Manufacturer
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD.
Date Cleared
2014-07-25
(63 days)
Product Code
GDW, GAG
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LS Series Linear Stapler and Reloads have application or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The CLC Series Curved Linear Cutter and Reloads is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
The LC Series Linear Cutter and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses.
The ELC Series Endoscopic Linear Cutter and Single Use Loading Unit have applications in general, abdominal, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.
Device Description
The proposed device, LS Series Linear Stapler and Reloads is a sterilized and disposable surgical instrument intended to be used in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. It places a double staggered row of titanium staples. It is available in 30 mm, 45 mm, 60 mm and 90 mm staple line length for use in various applications. Three staple sizes (2.5 mm, 3.5 mm, and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings. It has two configurations: (1) LS serials are staplers, and (2) LSC serials are Reloads. Each of them has various specifications.
The proposed device, CLC Series Curved Linear Cutter and Reloads are sterilized and disposable surgical instrument, which has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures. It is mainly suitable for low rectal resection and anastomosis of tissues where manual anastomosis is difficult. It places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. It is available in 37mm and 43mm lengths. Two staple sizes (3.8 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings. It has two configurations: (1) CLC serials are staplers, and (2) CLCC serials are reloads. Each of them has various specifications.
The proposed device, LC Series Linear Cutter Stapler and Reloads are sterilized and disposable surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses. It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. It is available in 60 mm, 80 mm and 100 mm lengths. Three staple sizes (3.8 mm, 4.2mm and 4.5 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings. It has two configurations: (1) LC serials are staplers, and (2) LCC serials are reloads. Each of them has various specifications.
The proposed device, ELC Series Endoscopic Linear Cutter and Single Use Loading Unit are sterilized and disposable-surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. Five staple sizes (2.0mm, 2.5mm, 4.0mm, and 4.8mm) are available to accommodate various tissue thicknesses. Each cartridge could be reloaded no more than 7 times for total 8 firings. It can be adapted for all of the reload sizes available. It has two configurations: (1) ELC-G and ELC-T serials are staplers, and (2) MG and RG serials are cartridges. Each of them has various specifications.
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