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510(k) Data Aggregation
K Number
K192566Device Name
Reach and CQ'ENCE Circular Staplers
Manufacturer
Reach Surgical, Inc.
Date Cleared
2019-10-17
(29 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
Reach Surgical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CQ ENCE Circular Staplers have application throughout the alimentary tract for the creation of end-to-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries.
Device Description
The REACH™ and SeCQure CO'ENCE™ Circular Staplers (CO'ENCE™ Circular Staplers) are sterile, single-use, hand-held, non-powered stapling devices used during general surgical procedures for the creation of end-to-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries. The Circular Staplers place a double-staggered, circular row of titanium staples while simultaneously resecting tissue when the device is manually activated. The device is provided in five head diameter sizes: 34mm, 31mm, 28mm, 25mm, and 21mm (product codes CS34, CS31, CS28, CS25, and CS21 respectively). Each size device can be purchased with a standard 27cm length shaft. The CS21 and SC25 can also be purchased with a longer, 35cm shaft (product codes CS21L, CS25L) to facilitate surgeon access to desired tissues. The CQ 'ENCE™ Circular Stapler allows the surgeon to control tissue compression by varying the closed staple height. The CQ ENCE Circular Stapler forms traditional B-shaped staples that are comprised of titanium. Safe removal of the device is facilitated by opening the instrument one full the Audible Indicator makes a clicking sound.
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K Number
K120179Device Name
REACH SURGICAL STAPLERS
Manufacturer
REACH SURGICAL, INC
Date Cleared
2012-05-23
(124 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
REACH SURGICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Circular Staplers with Staples 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 Linear Staplers with Single Use Loading Units have application in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Procedure Sets for Prolapse and Hemorrhoids have application for general surgical treatment of hemorrhoids.
The Endoscopic Linear Cutting Staplers with Single Use Loading Units have applications in general, 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.
The Linear Cutting Staplers with Single Use Loading Units have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
Device Description
The proposed device, Circular Staplers with Staples, 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, so a circular anastomosis is created.
The staple is available in two specifications which are 4.8 mm and 3.5 mm to be used per different thickness of the tissue.
The proposed device, Linear Staplers with Single Use Loading Units (SULU) is a sterilized and disposable surgical instrument intended to beused in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
It places a double staggered row of titanium staples and isavailable in 30 mm, 45 mm, 60 mm and 90 mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.5 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.
The proposed device, Procedure Sets for Prolapse and Hemorrhoids 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, Endoscopic Linear Cutting Staplers with Single Use Loading Units (SULU)is a sterilized and disposable surgical instrument, which has applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation 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. The size of the staples is decided by selecting 2.0 mm, 2.5 mm, 4.0 mm or 4.8 mm SULU.
The Endoscopic Linear Cutting Staplers are available in two kinds, which are Articulating and Straight. In addition, the Single Use Loading Units are also available in Articulating and Straight types. The Articulating Staplers could adjust the direction of the Single Use Loading Units (SULU) within a specified range if used together with Articulating SULU. The Articulating Staplers could also be used together with straight SULU without articulating features. The Straight stapler could only be used together with straight SULU.
When using the Endoscopic Linear Cutting Staplers with the 2.0, 2.5, 3.5 and 4.0 SULU, a 12 mm or larger trocar sleeve with a converter should be used. When using the Endoscopic Linear Cutting Staplers with the 4.8 SULU, a 15 mm trocar sleeve should be used. Endoscopic Linear Cutting Staplers may be reloaded and fired no more than 25 times in a single procedure. Each instrument can accommodate the following SULU specifications: 30-2.0, 30-2.5, 45-2.0, 45-2.5, 45-3.5, 45-4.0, 45-4.8,60-2.5, 60-3.5, 60-4.0, 60-4.8.
The proposed device, Linear Cutting Staplers with Single Use Loading Units(SULU)is a sterilized and disposable surgical instrument, which has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, 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. The Linear Cutting Staplers and SULU are available in 60 mm, 80 mm, and 100 mm lengths. SULU'are available in two staple sizes to accommodate various tissue thicknesses: 3.8 mm and 4.8 mm.
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K Number
K071023Device Name
REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C
Manufacturer
REACH SURGICAL, INC
Date Cleared
2008-08-28
(505 days)
Product Code
GDW, GAG
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
REACH SURGICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The REACH™ RCS Circular Stapler has 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.
Device Description
The REACH™ RCS Circular Stapler is a single patient use device which places a double staggered row of titanium staples. During staple formation, the instrument knife blade resects the excess tissue, creating a circular anastomosis.
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