{"product_id":"fda-510k-k222839-endowrist-stapler-30-45-and-sureform-30-45-60-systems","title":"FDA 510(k) K222839, EndoWrist Stapler 30\/45 and SureForm 30\/45\/60 Systems, by Intuitive Surgical, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K222839\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Intuitive Surgical, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e System, Surgical, Computer Controlled Instrument\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e NAY\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 09\/20\/2022 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/16\/2023\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429475451044,"sku":"FDA510K222839","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k222839-endowrist-stapler-30-45-and-sureform-30-45-60-systems","provider":"FOIA Document Source","version":"1.0","type":"link"}