Data / Medical devices / Japan / Unisis Corp.
Unisis Corp.: FDA-registered device maker in Koshigaya-shi Saitama, Japan, 2 510(k) clearances
Unisis Corp. is registered with the FDA (registration 9681709) in Koshigaya-shi Saitama, Japan. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 14, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681709
- FEI number
- 3003803331
- Address
- 2675-1 Nishikata, Koshigaya-shi Saitama, Japan, 343-0822
- Owner or operator
- UNISIS CORP. (9014974)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 1, 2009
- Registered through
- 2026
- Brand names listed
- EchoGlo needles, Needle, Conduction, Anesthesia, Needle, Conduction, Anesthetic, Needles, Lutz, Needles, Paracenetsis, UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blockade Needle, UNIEVER Disposable Spinal Anesthesia Needle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| General Surgery Tray | LRO | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Spinal, Short Term | MIA | 2 | Contract manufacturer | accessdata.fda.gov |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| January 14, 2015 | K142553 | UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle | BSP | Substantially Equivalent | Unisis Corp. | accessdata.fda.gov |
| October 31, 2014 | K141126 | UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE | BSP | Substantially Equivalent | Unisis Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Needle, Spinal, Short Term
- All makers of General Surgery Tray
- All makers of Sampler, Amniotic Fluid (Amniocentesis Tray)
Updated January 14, 2015. 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.