Company ยท US
Fujinon, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2012. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | 6 |
| GCJ | Laparoscope, General & Plastic Surgery | 6 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 4 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 3 |
| FDA | Enteroscope And Accessories | 2 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 |
| HIH | Hysteroscope (And Accessories) | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2012 | K120446 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 Fujinon, Inc. | FDS |
| Jul 26, 2012 | K112391 | FUJINON COLONOSCOPES Fujinon, Inc. | FDF |
| May 25, 2011 | K102466 | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR Fujinon, Inc. | FET |
| May 16, 2011 | K111243 | FUJINON ULTRASONIC PROCESSOR Fujinon, Inc. | FDS |
| Aug 7, 2009 | K091773 | FUJINON STERILE OVERTUBES Fujinon, Inc. | FED |
| Apr 22, 2009 | K090116 | FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 Fujinon, Inc., JP | FDF |
| Mar 16, 2007 | K063316 | FUJINON MODEL EG-530N TRANS NASAL INSERTION Fujinon, Inc. | FDS |
| Mar 1, 2007 | K063847 | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 Fujinon, Inc. | FDS |
| May 19, 2005 | K050907 | FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P Fujinon, Inc. | EOQ |
| Nov 24, 2004 | K042043 | FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 Fujinon, Inc. | FDS |
| Nov 18, 2004 | K042076 | FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 Fujinon, Inc. | FDT |
| Nov 10, 2004 | K041903 | FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 Fujinon, Inc. | FDF |
| Jun 7, 2004 | K040048 | FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM Fujinon, Inc. | FDA |
| Feb 11, 2000 | K993704 | GASTRO-INTESTINAL SYSTEM EN-410WM Fujinon, Inc. | FDA |
| Dec 16, 1998 | K983561 | FUJINON EVL-F VIDEO LAPROSCOPE Fujinon, Inc. | GCJ |
| Dec 12, 1997 | K971528 | ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) Fujinon, Inc. | IYO |
| Nov 22, 1995 | K954707 | BRONCHOSCOPE Fujinon, Inc. | EOQ |
| Apr 27, 1995 | K933544 | FUJINON VIDEO LAPORASCOPE Fujinon, Inc. | HIH |
| Apr 11, 1995 | K944759 | 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM Fujinon, Inc. | FET |
| Jul 8, 1994 | K933906 | CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION Fujinon, Inc. | FBN |
| Mar 29, 1994 | K930297 | FUJINON VIDEO LAPAROSCOPE, MODIFIED Fujinon, Inc. | FWF |
| Feb 16, 1994 | K932312 | FUJINON VIDEO LAPAROSCOPE -- MODIFIED Fujinon, Inc. | FET |
| Nov 1, 1993 | K933433 | MODIFIED BRONCHOSCOPE AND ACCESSORIES Fujinon, Inc. | EOQ |
| Jul 28, 1993 | K931223 | FUJINON VIDEO LAPAROSCOPE--THORACOSCOPY Fujinon, Inc. | GCJ |
| Jul 28, 1993 | K930817 | LAPAROSCOPIC LYMPHADENECTOMY Fujinon, Inc. | GCJ |
| Jul 28, 1993 | K925599 | FUJINON VIDEO LAPAROSCOPE-ADDITIONAL INTENDED USE Fujinon, Inc. | GCJ |
| Jun 25, 1993 | K926444 | FUJINON VIDEO LAPAROSCOPE, MODIFICATION Fujinon, Inc. | GCJ |
| Jan 23, 1992 | K912859 | FUJINON EVL-F Fujinon, Inc. | GCJ |
| Mar 5, 1991 | K902197 | FUJINON EVL-F (TENTATIVE) AND TROCAR Fujinon, Inc. | HET |
| May 22, 1990 | K894763 | FUJINON EDU SYSTEM Fujinon, Inc. | ITX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2013 | Fujinon Inc Fujinon/Fujifilm Ultrasonic Endoscope
Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment Terminated |
FDS | K120446 |
| Feb 9, 2011 | Fujinon Inc Fujinon Endoscope Series;
Model # EPX-4400 and EPX-4400HD.
Digital processing of images from endoscope. Terminated |
None listed | |
| Apr 5, 2006 | Fujinon Inc Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes. Terminated |
FDF | K041903 K944620 |