Aomori Olympus Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Aomori Olympus Co., Ltd.” (first 2003, latest 2005), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 139 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | 4 | 4 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Review panels
Most recent Aomori Olympus Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042160 | SONOSURG TROCAR | LFL | 2005-01-25 | 168 |
| K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM | LFL | 2004-09-08 | 90 |
| K033333 | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B | FGE | 2003-11-14 | 29 |
| K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | LFL | 2003-10-01 | 139 |
| K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | LFL | 2003-08-29 | 88 |
| K021672 | PANCREATIC DRAINAGE TUBE | FGE | 2003-04-16 | 330 |
| K022446 | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C | EOQ | 2003-03-28 | 246 |
Recalls
113 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2023-07-27.
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 Aomori Olympus Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Aomori Olympus Co., Ltd.” (first 2003, latest 2005), across 3 product codes in 3 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 Aomori Olympus Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aomori Olympus Co., Ltd. is 139 days.
Which FDA product codes appear under Aomori Olympus Co., Ltd.?
The most frequent FDA product codes under this applicant name are LFL (Instrument, Ultrasonic Surgical, 4); FGE (Stents, Drains And Dilators For The Biliary Ducts, 2); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 7 Aomori Olympus Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LFL, Aomori Olympus 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.