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510(k) K841396

Device
TRANSFER TROLLEY
Applicant
SETMA, INC.
510(k) number
K841396
Product code
FDA  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-07
Date received
1984-04-03
Regulation
876.1500
Classification name
Enteroscope And Accessories
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FDA  #

510(k), Device, Applicant table
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
K191330Arc EnterocuffBoddingtons Plastics, Ltd.2020-01-31
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

Legacy Summary#

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FDA Review#

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