Gunze Limited
Ayabe, Kyoto, JP
Gunze Limited appears in FDA device records in Ayabe, Kyoto, JP. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Gunze Limited between 2013 and 2022. The busiest year on record is 2022, with 3. The most recent is 2022, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2020 | 1 |
| 2022 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221487 | NEOVEIL Staple Line Reinforcement | OXC | Substantially Equivalent | |
| K213498 | PELNAC Meshed Bilayer Wound Matrix | KGN | Substantially Equivalent | |
| K213573 | PELNAC Wound Matrix | KGN | Substantially Equivalent | |
| K191992 | PELNAC Bilayer Wound Matrix | KGN | Substantially Equivalent | |
| K130997 | NEOVEIL | OXC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain