510(k) Report

Devices descending from K143556

19 later devices reach Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation20240—
+1K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton20231—
+1K213195Balloon BS-3Fujifilm Corporation20212—
+1K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation20195—
+1K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation20192—
+1K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.20178—
+1K153483Balloon controller PB-30Fujifilm Medical Systems U.S.A, Inc.20151—
+2K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+2K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.20260—
+2K242635Endoscopic Distal Attachment (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.20250—
+2K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation20243—
+2K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation20231—
+2K210915Pathfinder Endoscope CapNeptune Medical, Inc.20210—
+2K193123FUJIFILM Distal Cap Models 33-40Fujifilm Corporation20192—
+3K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…Fujifilm Corporation20260—
+3K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation20250—
+3K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+3K242779Hood (DH-083ST)Fujifilm Corporation20240—
+3K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2Fujifilm Corporation20210—