Data / Medical devices / Japan / Unisis Corp
Unisis Corp: FDA-registered device maker in Kita-Hiroshima-shi Hokkaido, Japan, 7 510(k) clearances
Unisis Corp is registered with the FDA (registration 3020983482) in Kita-Hiroshima-shi Hokkaido, Japan. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 14, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3020983482
- Address
- 1-2-8 Wattsu Industrial Complex, Kita-Hiroshima-shi Hokkaido, Japan, 061-1281
- Owner or operator
- Unisis Corp (10083347)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 12, 2021
- Registered through
- 2026
- Brand names listed
- Uniever Disposable Epidural Anesthesia Needle, Uniever Disposable Nerve Blockade Needle, Uniever Disposable Spinal Anesthesia Needle
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, 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 |
|---|---|---|---|---|---|---|
| June 14, 2018 | K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors | MIA | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| June 12, 2018 | K172823 | Portex NRFit Epidural Needles | BSP | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| January 25, 2018 | K171968 | EchoGlo Needle | BSP | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| 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 |
| May 1, 2009 | K090261 | PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G | BSP | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| January 29, 1999 | K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | MIA | Substantially Equivalent | Sims Portex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of General Surgery Tray
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Needle, Spinal, Short Term
Updated June 14, 2018. 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.