Data / Medical devices / Japan / Gunze Medical Limited
Gunze Medical Limited: FDA-registered device maker in Osaka, Japan, 4 510(k) clearances
Gunze Medical Limited is registered with the FDA (registration 3027419979) in Osaka, Japan. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 26, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027419979
- Address
- 5F, JRE Dojima Tower, 2-4-27, Dojima, Kita-ku, Osaka, Japan, 5300003
- Owner or operator
- GUNZE MEDICAL LIMITED (10088147)
- Roles
- Exporter to the US
- First device listed
- June 1, 2023
- Registered through
- 2026
- Brand names listed
- NEOVEIL Sheet Type Suture and Staple Line Reinforcement Material; NEOVEIL Tube Type Staple Line Reinforcement Material, NEOVEIL Staple Line Reinforcement, TheraGenesis Meshed Bilayer Wound Matrix, TheraGenesis Non-Meshed Bilayer Wound Matrix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | 2 | Exporter to the US | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| August 26, 2022 | K221487 | NEOVEIL Staple Line Reinforcement | OXC | Substantially Equivalent | Gunze Limited | accessdata.fda.gov |
| July 14, 2022 | K213498 | PELNAC Meshed Bilayer Wound Matrix | KGN | Substantially Equivalent | Gunze Limited | accessdata.fda.gov |
| April 29, 2020 | K191992 | PELNAC Bilayer Wound Matrix | KGN | Substantially Equivalent | Gunze Limited | accessdata.fda.gov |
| November 15, 2013 | K130997 | NEOVEIL | OXC | Substantially Equivalent | Gunze Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Absorbable, Staple Line Reinforcement
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated August 26, 2022. 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.