{"product_id":"fda-510k-k231553","title":"FDA 510(k) K231553, OverStitch NXT Endoscopic Suturing System, by Apollo Endosurgery, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eEndoscopic Tissue Approximation Device\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK231553\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e OverStitch NXT Endoscopic Suturing System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Apollo Endosurgery, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e876.1500\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eOCW\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e05\/30\/2023\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 06\/29\/2023\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\u003eGeneral \u0026amp; Plastic Surgery\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 554\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 227\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 327\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313334485156,"sku":"FDA510K231553","price":942.03,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k231553","provider":"FOIA Document Source","version":"1.0","type":"link"}