FDA.report

510(k) K191330

Device
Arc Enterocuff
Applicant
Boddingtons Plastics, Ltd.
510(k) number
K191330
Product code
FDA
Decision
Substantially Equivalent (SESE)
Decision date
2020-01-31
Date received
2019-05-16
Regulation
876.1500
Classification name
Enteroscope And Accessories
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
Shimaa Elsawy
Address
Wheelbarrow Park Estate, Pattenden Ln., Marden Tonbridge GB TN12 9QJ TN12 9QJ

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FDA

510(k)DeviceApplicantDecision date
K260314Ancora-SBAspero Medical, Inc.2026-05-01
K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation2025-09-26
K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation2024-06-13
K231323Ancora-SBAspero Medical, Inc.2023-08-31
K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton2023-01-11
K213195Balloon BS-3Fujifilm Corporation2021-10-29
K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation2019-06-24
K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation2019-02-27
K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc.2015-08-20
K071254SMALL INTESTINAL VIDEOSCOPE SYSTEMOlympus Medical Systems Corporation2008-03-25
K060923NAVIAID BGE DEVICE, MODEL 21-001Smart Medical Systems , Ltd.2006-08-15
K060235ENDO-EASE ENDOSCOPIC OVERTUBESpirus Medical, Inc.2006-08-04
K040048FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEMFujinon, Inc.2004-06-07
K031256XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPEOlympus Opto-Electronics Co., Ltd.2003-07-23
K993704GASTRO-INTESTINAL SYSTEM EN-410WMFujinon, Inc.2000-02-11