Data / Medical devices / Japan / Kono Seisakusho
Kono Seisakusho: FDA-registered device maker in Ichikawa Chiba, Japan, 2 510(k) clearances
Kono Seisakusho is registered with the FDA (registration 3013849323) in Ichikawa Chiba, Japan. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 23, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013849323
- Address
- Soya 2-11-10, Ichikawa Chiba, Japan, 272-0832
- Owner or operator
- Kono Seisakusho (10077957)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 6, 2020
- Registered through
- 2026
- Brand names listed
- CROWNJUN Micro Scale, CROWNJUN Micro Sheet K, CROWNJUN Nylon Suture, CROWNJUN Super Micro Sheet K, Double Retractor, PICOCLAMP, Single Retractor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Vascular | DXC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 23, 2023 | K230281 | PICOCLAMP | DXC | Substantially Equivalent | Kono Seisakusho Co., Ltd. | accessdata.fda.gov |
| May 29, 2020 | K192420 | Crownjun Nylon Suture | GAR | Substantially Equivalent | Kono Seisakusho Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor
- All makers of Tape, Measuring, Rulers And Calipers
- All makers of Clamp, Vascular
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
Updated October 23, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.