Gunze Limited
FDA Regulatory Profile
Gunze Limited appears in FDA public data with 0 recalls, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 26, 2022.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K221487 | NEOVEIL Staple Line Reinforcement | August 26, 2022 |
| K213498 | PELNAC Meshed Bilayer Wound Matrix | July 14, 2022 |
| K213573 | PELNAC Wound Matrix | February 9, 2022 |
| K191992 | PELNAC Bilayer Wound Matrix | April 29, 2020 |
| K130997 | NEOVEIL | November 15, 2013 |