Company ยท JP
Gunze Limited
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2022. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2022 | K221487 | NEOVEIL Staple Line Reinforcement Gunze Limited, JP | OXC |
| Jul 14, 2022 | K213498 | PELNAC Meshed Bilayer Wound Matrix Gunze Limited, JP | KGN |
| Feb 9, 2022 | K213573 | PELNAC Wound Matrix Gunze Limited, JP | KGN |
| Apr 29, 2020 | K191992 | PELNAC Bilayer Wound Matrix Gunze Limited, JP | KGN |
| Nov 15, 2013 | K130997 | NEOVEIL Gunze Limited, JP | OXC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||