{"product_id":"fda-510k-k241169","title":"FDA 510(k) K241169, Entarik NI Feeding Tube System, by Gravitas Medical, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eTubes, Gastrointestinal (And Accessories)\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK241169\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Entarik NI Feeding Tube System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Gravitas Medical, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e876.5980\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eKNT\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e04\/26\/2024\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 11\/22\/2024\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 2,286\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,803\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 483\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313334812836,"sku":"FDA510K241169","price":1258.49,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k241169","provider":"FOIA Document Source","version":"1.0","type":"link"}