Fujinon Inc
FDA Regulatory Profile
Fujinon Inc appears in FDA public data with 1 recall, 30 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0112-2014, Class II) was initiated on July 31, 2013. Its most recent 510(k) clearance was granted on August 13, 2012.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 30
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0112-2014 | Class II | Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and per | July 31, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K120446 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 | August 13, 2012 |
| K112391 | FUJINON COLONOSCOPES | July 26, 2012 |
| K102466 | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR | May 25, 2011 |
| K111243 | FUJINON ULTRASONIC PROCESSOR | May 16, 2011 |
| K091773 | FUJINON STERILE OVERTUBES | August 7, 2009 |
| K090116 | FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 | April 22, 2009 |
| K063316 | FUJINON MODEL EG-530N TRANS NASAL INSERTION | March 16, 2007 |
| K063847 | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 | March 1, 2007 |
| K050907 | FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P | May 19, 2005 |
| K042043 | FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 | November 24, 2004 |
| K042076 | FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 | November 18, 2004 |
| K041903 | FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 | November 10, 2004 |
| K040048 | FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM | June 7, 2004 |
| K993704 | GASTRO-INTESTINAL SYSTEM EN-410WM | February 11, 2000 |
| K983561 | FUJINON EVL-F VIDEO LAPROSCOPE | December 16, 1998 |
| K971528 | ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) | December 12, 1997 |
| K954707 | BRONCHOSCOPE | November 22, 1995 |
| K933544 | FUJINON VIDEO LAPORASCOPE | April 27, 1995 |
| K944759 | 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM | April 11, 1995 |
| K933906 | CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION | July 8, 1994 |