Fujinon, Inc.
Medical device manufacturer in Wayne, NJ.
30510(k) clearances
0PMA approvals
2recalls
Device types
- GCJ Laparoscope, General & Plastic Surgery 6
- FDS Gastroscope And Accessories, Flexible/Rigid 5
- EOQ Bronchoscope (Flexible Or Rigid) 3
- FET Endoscopic Video Imaging System/Component… 3
- FDF Colonoscope And Accessories, Flexible/Rigid 3
- FDA Enteroscope And Accessories 2
- ITX Transducer, Ultrasonic, Diagnostic 1
- HET Laparoscope, Gynecologic (And Accessories) 1
- FWF Camera, Television, Endoscopic, Without Audio 1
- FBN Choledochoscope And Accessories… 1
- HIH Hysteroscope (And Accessories) 1
- IYO System, Imaging, Pulsed Echo, Ultrasonic 1
- FDT Duodenoscope And Accessories, Flexible/Rigid 1
- FED Endoscopic Access Overtube, Gastroenterology… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2FDS · Traditional | 08/13/2012SE |
| K112391 | Fujinon ColonoscopesFDF · Special | 07/26/2012SE |
| K102466 | Fujinon EPX-4440HD Digital Video ProcessorFET · Traditional | 05/25/2011SE |
| K111243 | Fujinon Ultrasonic ProcessorFDS · Special | 05/16/2011SE |
| K091773 | Fujinon Sterile OvertubesFED · Special | 08/07/2009SE |
| K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15FDF · Traditional | 04/22/2009SE |
| K063316 | Fujinon Model EG-530N Trans Nasal InsertionFDS · Traditional | 03/16/2007SE |
| K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700FDS · Traditional | 03/01/2007SE |
| K050907 | Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PEOQ · Traditional | 05/19/2005SE |
| K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5FDS · Traditional | 11/24/2004SE |
| K042076 | Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5FDT · Traditional | 11/18/2004SE |
| K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5FDF · Traditional | 11/10/2004SE |
| K040048 | Fujinon Double Balloon Enteroscopy SystemFDA · Traditional | 06/07/2004SE |
| K993704 | Gastro-Intestinal System EN-410WMFDA · Traditional | 02/11/2000SE |
| K983561 | Fujinon Evl-F Video LaproscopeGCJ · Special | 12/16/1998SE |
| K971528 | Endoscopically Deliveralbe Ultrasound Point Porbe System (Endoscopy)IYO · Traditional | 12/12/1997SE |
| K954707 | BronchoscopeEOQ · Traditional | 11/22/1995SE |
| K933544 | Fujinon Video LaporascopeHIH · Traditional | 04/27/1995SE |
| K944759 | 200 Series Gastro-Intestinal Video SystemFET · Traditional | 04/11/1995SE |
| K933906 | Choledochoscope/Endoscope ModificationFBN · Traditional | 07/08/1994SE |
| K930297 | Fujinon Video Laparoscope, ModifiedFWF · Traditional | 03/29/1994SE |
| K932312 | Fujinon Video Laparoscope -- ModifiedFET · Traditional | 02/16/1994SE |
| K933433 | Modified Bronchoscope and AccessoriesEOQ · Traditional | 11/01/1993SE |
| K931223 | Fujinon Video Laparoscope--ThoracoscopyGCJ · Traditional | 07/28/1993SE |
| K930817 | Laparoscopic LymphadenectomyGCJ · Traditional | 07/28/1993SE |
| K925599 | Fujinon Video Laparoscope-Additional Intended UseGCJ · Traditional | 07/28/1993SE |
| K926444 | Fujinon Video Laparoscope, ModificationGCJ · Traditional | 06/25/1993SE |
| K912859 | Fujinon Evl-FGCJ · Traditional | 01/23/1992SE |
| K902197 | Fujinon Evl-F (Tentative) and TrocarHET · Traditional | 03/05/1991SE |
| K894763 | Fujinon Edu SystemITX · Traditional | 05/22/1990SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0112-2014 Class II | Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of…A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing… | 07/31/2013Terminated |
| Z-1067-2011 | Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images…The FICE feature installed in video endoscopic processors is being disabled since this feature should have… | 01/07/2011Terminated |