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The PROXIMATE® Curved and Straight Intraluminal Staplers have application throughout the alimentary tract for end to end, end to side and side to side anastomoses including application throughout the anal canal to perform surgical treatment for hemorrhoidal disease.

All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510 (k) #940967.

This document does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is a 510(k) summary for the PROXIMATE® Curved and Straight Intraluminal Staplers, stating that its performance and characteristics are identical to a previously cleared device (K940967).

Therefore, specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for this specific submission (K983536) are not present. The submission relies on establishing substantial equivalence to a predicate device.

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