Total clearances
8
2020-11-13 → 2025-07-16
Name variants in FDA filings: Kerecis Limited / Kerecis
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| KGN |
Wound Dressing With Animal-Derived Material(S) |
Unclassified |
Unknown |
3 |
2025-07-16 |
| OXH |
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
Class II |
General, Plastic Surgery |
2 |
2025-07-15 |
| NPL |
Barrier, Animal Source, Intraoral |
Class II |
Dental |
2 |
2022-09-30 |
| OWY |
— |
— |
— |
1 |
2025-06-04 |
Filings
All 510(k) clearances (8)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-07-16 |
K251845 |
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus |
KGN |
Unclassified |
Unknown |
| 2025-07-15 |
K251844 |
Kerecis SurgiBind (50241) |
OXH |
Class II |
General, Plastic Surgery |
| 2025-06-04 |
K243843 |
Tendon Protect (50242) |
OWY |
— |
— |
| 2024-08-21 |
K241080 |
Kerecis Parvus (50207) |
KGN |
Unclassified |
Unknown |
| 2022-09-30 |
K213904 |
Kerecis Oral |
NPL |
Class II |
Dental |
| 2022-06-29 |
K213231 |
Kerecis Silicone |
KGN |
Unclassified |
Unknown |
| 2021-05-02 |
K202430 |
Kerecis Reconstruct |
OXH |
Class II |
General, Plastic Surgery |
| 2020-11-13 |
K192612 |
Kerecis Gingiva Graft |
NPL |
Class II |
Dental |