Data / Medical devices / Japan / Hakko Co., Ltd.
Hakko Co., Ltd.: FDA-registered device maker in CHIKUMA-SHI Nagano, Japan, 5 510(k) clearances
Hakko Co., Ltd. is registered with the FDA (registration 9611481) in CHIKUMA-SHI Nagano, Japan. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 25, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611481
- FEI number
- 3002807220
- Address
- 1490 O-aza Isobe, CHIKUMA-SHI Nagano, Japan, 389-0806
- Owner or operator
- HAKKO CO., LTD. (8030409)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- November 13, 2007
- Registered through
- 2026
- Brand names listed
- Biosuc Fine Aspiration, Echostim Facet Tip, Hakko Spinal Needle, Soft Tissue Retractor, Sonopsy Needle, Stimuplex (DIG,RC, A), Tuohy Epidural Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Manufacturer | accessdata.fda.gov |
| Ring (Wound Protector), Drape Retention, Internal | KGW | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Stimulator, Nerve, Battery-Powered | BXN | 2 | Contract manufacturer, Contract sterilizer | 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 |
|---|---|---|---|---|---|---|
| April 25, 2007 | K063380 | ECHOSTIM FACET TIP | BSP | Substantially Equivalent | Havel'S, Inc. | accessdata.fda.gov |
| April 4, 2002 | K013108 | BIOSUC | KNW | Substantially Equivalent | Hakko Medical Co., Ltd. | accessdata.fda.gov |
| March 12, 2002 | K013109 | SONOPSY | FCG | Substantially Equivalent | Hakko Medical Co., Ltd. | accessdata.fda.gov |
| March 19, 1997 | K961152 | TUOHY EPIDURAL NEEDLES | BSP | Substantially Equivalent | Hakko Shoji Co., Ltd. | accessdata.fda.gov |
| March 19, 1997 | K961151 | SPINAL NEEDLES | BSP | Substantially Equivalent | Hakko Shoji Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Stimulator, Nerve, Battery-Powered
- All makers of Biopsy Needle
- All makers of Ring (Wound Protector), Drape Retention, Internal
- All makers of Instrument, Biopsy
Updated April 25, 2007. 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.