510(k) K260058
- Device
- Kerecis Express (50250)
- Applicant
- Kerecis Limited
- 510(k) number
- K260058
- Product code
- KGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-30
- Date received
- 2026-01-08
- Classification name
- Wound Dressing With Animal-Derived Material(S)
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Skuli Magnusson
- Address
- Sundastraeti 38 P.O. Box 151 Isafjordur IS 400 400
FDA Registration Numbers#
- 3015980493
- 3012973796
- 9680579
- 2249852
- 1531062
- 3003636207
- 1720734
- 3015309358
- 1649518
- 1225991
- 3015542130
- 3039169663
- 3016615875
- 1648579
- 3046781339
- 3009317711
- 2030598
- 3010097129
- 1929833
- 3042708438
- 2245304
- 9614442
- 3014982332
- 8043484
- 3007124979
- 3022133572
- 3004713654
- 3017633586
- 2245539
- 3010155661
- 3004117927
- 3003300673
- 2530154
- 3039592366
- 3015525200
- 3014146451
- 3015058854
- 3011680766
- 3004170064
- 2245437
- 1645368
- 3014498807
- 3010668881
- 3009882464
- 3013820501
- 3019356409
- 1720929
- 3015282703
- 3009988302
- 3032911850
- 1000393132
- 3042617688
- 3004799623
- 2032542
- 2135152
- 1064858
- 1221816
- 3013517171
- 3010894343
- 3027419979
- 3004431266
- 1043214
- 2024024
- 3009109670
- 1424263
- 3027448274
- 1450662
- 3031600472
- 3017107376
- 3013012623
- 3012535730
- 3012823434
- 3017391151
- 3017660750
- 3012494290
- 8043792
- 3010824458
- 3007321028
- 3011649314
Source Documents#
Other 510(k) Records For Product Code KGN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260920 | Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-125X25AA); Accelagen Advanced Surgical Collagen Strip, 250x25x2mm (CG-250X25AA) | Berkeley Advanced Biomaterials | 2026-10-22 |
| K260530 | epi-ConneKt™ Wound Matrix | MLM Biologics, Inc. | 2026-10-15 |
| K260652 | ColActive Plus | Covalon Technologies, Ltd. | 2026-09-09 |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) | Berkeley Advanced Biomaterials | 2026-08-27 |
| K260596 | Collagen Wound Powder | Ventris Medical | 2026-07-02 |
| K260669 | Endoform Dermal Template | Aroa Biosurgery , Ltd. | 2026-06-24 |
| K253521 | ECMT-100 WMD | Ecm Therapeutics, Inc. | 2026-06-18 |
| K253204 | Catalyze | BioTissue Holdings, Inc. | 2026-06-05 |
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | 2026-06-03 |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | 2026-06-03 |
| K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2026-05-14 |
| K260532 | Derma-Gide | Geistlich Pharma AG | 2026-03-19 |
| K260218 | LacertaMatrix | Lacerta Life Sciences | 2026-02-19 |
| K253140 | CollOvine™ Wound Powder | Ovigenex, LLC | 2026-02-10 |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | 2026-01-22 |