510(k) K243071
- Device
- Bovine Dermis Collagen Dermal Matrix
- Applicant
- Collagen Matrix, Inc.
- 510(k) number
- K243071
- Product code
- KGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-19
- Date received
- 2024-09-27
- 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
- No
Applicant Contact#
- Contact
- Devin Dragon
- Address
- 15 Thornton Rd. Oakland NJ US 07436 07436
FDA Registration Numbers#
- 3036710971
- 3012448339
- 3017633586
- 3010668881
- 3009109670
- 1319660
- 3014498807
- 2435946
- 3002636527
- 3007663067
- 1047843
- 8043396
- 2530154
- 3027448274
- 3003418325
- 3009656988
- 3007735241
- 2530957
- 9614442
- 3013517171
- 1649518
- 1835959
- 3025316685
- 3031600472
- 3031238659
- 3008374791
- 3004170064
- 1929833
- 3009988302
- 3011191255
- 3015309358
- 3003300673
- 2431866
- 1043214
- 9680579
- 1066741
- 3016429246
- 1645368
- 3039169663
- 3043861816
- 3009882464
- 3021784063
- 2245437
- 2032542
- 3004799623
- 8043484
- 3031743608
- 3018348
- 1121308
- 1531062
- 3004189237
- 3011649314
- 3015442987
- 3013820501
- 3034456223
- 3009973323
- 3042617688
- 8043792
- 3017660750
- 1225991
- 3014820861
- 1646434
- 3006802076
- 3007124979
- 1221816
- 3017399129
- 1058584
- 3015980493
- 1060680
- 3011276344
- 3017391151
- 3007738736
- 3042708438
- 3015542130
- 3010894343
- 2135152
- 2245539
- 3013012623
- 3007594734
Source Documents#
Other 510(k) Records For Product Code KGN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252673 | LacertaMatrix | Lacerta Life Science | 2025-12-22 |
| K253339 | Theracor | Stimlabs, LLC | 2025-12-22 |
| K250864 | MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG | 2025-12-19 |
| K242100 | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. | 2025-10-16 |