The Olympus Optical Co.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “The Olympus Optical Co.” (first 1998, latest 2003), across 15 product codes in 5 review panels. Median 510(k) review time under this name: 68 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | 4 | 4 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 | 3 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Plus 5 more product codes.
Review panels
- Gastroenterology and Urology (10)
- General and Plastic Surgery (5)
- Ear, Nose and Throat (4)
- Radiology (2)
- Orthopedic (1)
Most recent The Olympus Optical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032066 | SONOSURG SYSTEM | LFL | 2003-10-03 | 92 |
| K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | KNS | 2003-03-24 | 62 |
| K021962 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | LFL | 2003-02-12 | 243 |
| K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES | EOQ | 2003-01-31 | 60 |
| K023272 | DISPOSABLE ASPIRATION NEEDLE NA-200H | FCG | 2002-12-23 | 83 |
| K023767 | UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES | GEI | 2002-11-29 | 17 |
| K012074 | XBO1-824-18/19/20 BIOPSY FORCEPS | OCZ | 2001-09-25 | 85 |
| K012073 | OLYMPUS SPRAY CATHETER PW-6C-1 | EOQ | 2001-08-10 | 39 |
| K011869 | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | EOB | 2001-07-25 | 41 |
| K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z | FDS | 2001-05-15 | 29 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Olympus Optical Co..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Olympus Optical Co.?
FDA lists 22 510(k) clearances under the applicant name “The Olympus Optical Co.” (first 1998, latest 2003), across 15 product codes in 5 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 The Olympus Optical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Olympus Optical Co. is 68 days.
Which FDA product codes appear under The Olympus Optical Co.?
The most frequent FDA product codes under this applicant name are LFL (Instrument, Ultrasonic Surgical, 4); EOQ (Bronchoscope (Flexible Or Rigid), 3); FDF (Colonoscope And Accessories, Flexible/Rigid, 2).
Next steps
- See all 22 The Olympus Optical Co. clearances with predicates and recalls
- Run predicate analysis for product code LFL, The Olympus Optical Co.'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.