Narishige Co., Ltd.: FDA clearances and approvals
Narishige Co., Ltd. has 20 FDA 510(k) clearances (first 2000, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time: 32 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 88 |
| 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 |
|---|---|---|---|
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | 20 | 20 |
Review panels
Most recent Narishige Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120877 | MICROMANIPULATOR SET | MQJ | 2012-06-20 | 89 |
| K113712 | IM-11 PNEUMATIC MICROINJECTOR | MQJ | 2012-03-15 | 87 |
| K011420 | MM-87 MOTOR-DRIVE MANIPULATOR | MQJ | 2001-06-12 | 34 |
| K010298 | MN-4 COARSE MANIPULATOR | MQJ | 2001-03-16 | 44 |
| K003304 | IM-6 MICROINJECTOR | MQJ | 2000-11-22 | 33 |
| K003303 | IM-5B MICROINJECTOR | MQJ | 2000-11-22 | 33 |
| K003302 | IM-5A INJECTOR | MQJ | 2000-11-22 | 33 |
| K003300 | MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR | MQJ | 2000-11-22 | 33 |
| K003298 | MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR | MQJ | 2000-11-21 | 32 |
| K002850 | MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR | MQJ | 2000-10-05 | 22 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Narishige Co., Ltd..
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 Narishige Co., Ltd. have?
Narishige Co., Ltd. has 20 FDA 510(k) clearances (first 2000, latest 2012), across 1 product code in 1 review panel.
How long does FDA take to clear Narishige Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Narishige Co., Ltd.'s cleared 510(k)s is 32 days.
What devices does Narishige Co., Ltd. make?
Its most frequent FDA product codes are MQJ (Micromanipulators And Microinjectors, Assisted Reproduction, 20).
Has Narishige Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Narishige Co., Ltd. Related entities may recall under other names.
Next steps
- See all 20 Narishige Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQJ, Narishige Co., Ltd.'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.