FDA 510(k) Applications for Medical Device Product Code: FDA (Enteroscope And Accessories)

FDA 510(k) Applications for Medical Device Product Code "FDA"
(Enteroscope And Accessories)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K231323	Aspero Medical, Inc.	Ancora-SB	08/31/2023
K191330	Boddingtons Plastics Ltd	Arc Enterocuff	01/31/2020
K213195	FUJIFILM Corporation	Balloon BS-3	10/29/2021
K183032	FUJIFILM Corporation	FUJIFILM Double Balloon Endoscope EI580BT	06/24/2019
K183683	FUJIFILM Corporation	FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5	02/27/2019
K223295	FUJIFILM Corporaton	Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D	01/11/2023
K143556	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.	Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T	08/20/2015
K040048	FUJINON, INC.	FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM	06/07/2004
K993704	FUJINON, INC.	GASTRO-INTESTINAL SYSTEM EN-410WM	02/11/2000
K071254	OLYMPUS MEDICAL SYSTEMS CORPORATION	SMALL INTESTINAL VIDEOSCOPE SYSTEM	03/25/2008
K031256	OLYMPUS OPTO-ELECTRONICS CO., LTD.	XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE	07/23/2003
K060923	SMART MEDICAL SYSTEMS, LTD.	NAVIAID BGE DEVICE, MODEL 21-001	08/15/2006
K060235	SPIRUS MEDICAL, INC.	ENDO-EASE ENDOSCOPIC OVERTUBE	08/04/2006