Fujinon, Inc.: FDA clearances and approvals
Fujinon, Inc. has 30 FDA 510(k) clearances (first 1990, latest 2012), across 14 product codes in 5 review panels. Median 510(k) review time: 154 days. openFDA lists 3 product recalls by a recalling firm named Fujinon, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 262 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 6 | 6 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 5 | 5 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 | 3 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 3 | 3 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 3 | 3 |
| FDA | Enteroscope And Accessories | 2 | 2 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
Plus 4 more product codes.
Review panels
- Gastroenterology and Urology (16)
- General and Plastic Surgery (7)
- Ear, Nose and Throat (3)
- Obstetrics and Gynecology (2)
- Radiology (2)
Most recent Fujinon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120446 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 | FDS | 2012-08-13 | 181 |
| K112391 | FUJINON COLONOSCOPES | FDF | 2012-07-26 | 342 |
| K102466 | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR | FET | 2011-05-25 | 268 |
| K111243 | FUJINON ULTRASONIC PROCESSOR | FDS | 2011-05-16 | 13 |
| K091773 | FUJINON STERILE OVERTUBES | FED | 2009-08-07 | 52 |
| K090116 | FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 | FDF | 2009-04-22 | 91 |
| K063316 | FUJINON MODEL EG-530N TRANS NASAL INSERTION | FDS | 2007-03-16 | 134 |
| K063847 | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 | FDS | 2007-03-01 | 64 |
| K050907 | FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P | EOQ | 2005-05-19 | 38 |
| K042043 | FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 | FDS | 2004-11-24 | 118 |
20 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2013-07-31.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Fujinon, Inc. have?
Fujinon, Inc. has 30 FDA 510(k) clearances (first 1990, latest 2012), across 14 product codes in 5 review panels.
How long does FDA take to clear Fujinon, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Fujinon, Inc.'s cleared 510(k)s is 154 days.
What devices does Fujinon, Inc. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 6); FDS (Gastroscope And Accessories, Flexible/Rigid, 5); EOQ (Bronchoscope (Flexible Or Rigid), 3).
Has Fujinon, Inc. had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Fujinon, Inc; the most recent began 2013-07-31. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 30 Fujinon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Fujinon, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.