Olympus Optical Co., Ltd.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Olympus Optical Co., Ltd.” (first 1996, latest 2003), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Olympus, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 2 |
| GWG | Endoscope, Neurological | 2 | 2 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Plus 9 more product codes.
Review panels
- Gastroenterology and Urology (11)
- General and Plastic Surgery (5)
- Ear, Nose and Throat (4)
- Neurology (3)
- Obstetrics and Gynecology (2)
- Radiology (1)
Most recent Olympus Optical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | EOQ | 2003-10-16 | 10 |
| K031305 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | LFL | 2003-09-23 | 152 |
| K031648 | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V | EOB | 2003-07-24 | 57 |
| K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE | FCL | 2003-07-16 | 9 |
| K031347 | ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 | ODG | 2003-05-09 | 10 |
| K024138 | HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE | GEI | 2003-03-12 | 86 |
| K021852 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES | GEI | 2003-02-11 | 251 |
| K022445 | VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V | HIH | 2003-01-24 | 183 |
| K024033 | XTJF-160AF DUODENOVIDEOSCOPE | FDT | 2002-12-20 | 14 |
| K023280 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES | GEI | 2002-12-19 | 79 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Olympus Optical Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Olympus Medical Systems Corp. (190 510(k)s)
- Olympus Corp. (149 510(k)s)
- Olympus America, Inc. (149 510(k)s)
- Olympus Winter & Ibe GmbH (43 510(k)s)
- Olympus Surgical Technologies America (14 510(k)s)
- Olympus Diagnostica GmbH (4 510(k)s)
- Olympus Life & Material Science Europa GmbH (Irish (3 510(k)s)
- Olympus Life Science Research Europa GmbH (Europa) (3 510(k)s)
- Olympus Terumo Biomaterials Corporation (3 510(k)s)
- Olympus Corp of America (2 510(k)s)
- Olympus Opto-Electronics Co., Ltd. (2 510(k)s)
- Olympus America Inc. / Scientific Equipment Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Olympus Optical Co., Ltd.?
FDA lists 26 510(k) clearances under the applicant name “Olympus Optical Co., Ltd.” (first 1996, latest 2003), across 19 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Olympus Optical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Olympus Optical Co., Ltd. is 84 days.
Which FDA product codes appear under Olympus Optical Co., Ltd.?
The most frequent FDA product codes under this applicant name are FDS (Gastroscope And Accessories, Flexible/Rigid, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); EOB (Nasopharyngoscope (Flexible Or Rigid), 2).
Next steps
- See all 26 Olympus Optical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FDS, Olympus Optical Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.