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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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