510(k) K241904
- Device
- DermiSphere Dermal Template
- Applicant
- Fesariustherapeutics, Inc.
- 510(k) number
- K241904
- Product code
- KGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-06
- Date received
- 2024-07-01
- 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
Related Records
Applicant Contact
- Contact
- Yulia Sapir-Lekhovitser
- Address
- 760 Parkside Ave., Suite 218 Brooklyn NY US 11226 11226
FDA Registration Numbers
- 1929833
- 8043396
- 3027448274
- 2029275
- 2024024
- 3017297225
- 2245539
- 3009882464
- 3012535730
- 3010668881
- 3015980493
- 3003636207
- 3009317711
- 3016615875
- 3031238659
- 3004146122
- 3007321028
- 3015309358
- 3015238043
- 3031743608
- 1646434
- 3019356409
- 3010600625
- 3003300673
- 3007663067
- 3017399129
- 3005920706
- 3004431266
- 3015542130
- 1221816
- 3030067857
- 1047843
- 3002907620
- 2530957
- 9680579
- 3008770963
- 2530154
- 3010894343
- 1225991
- 2245304
- 1835959
- 3005433617
- 3015442987
- 3025316685
- 1720734
- 1064858
- 3017633586
- 1648579
- 3008374791
- 8043792
- 3014498807
- 3014982332
- 3004170064
- 3007594734
- 3032911850
- 1220477
- 1121308
- 1650372
- 3031600472
- 3012823434
- 3036710971
- 3013012623
- 3017660750
- 3004799623
- 3027419979
- 3004117927
- 1649518
- 2245437
- 3012973796
- 3004189237
- 3006802076
- 2431866
- 3011276344
- 3039592366
- 3014820861
- 3013820501
- 9680091
- 3027517726
- 3009109670
- 3010187826
Source Documents
Other 510(k) Records For Product Code KGN
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253339 | Theracor | Stimlabs, LLC | 2025-12-22 |
| K252673 | LacertaMatrix | Lacerta Life Science | 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 |
| K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 2025-10-10 |
| K250397 | Helios Dermal Scaffold | Helios Biomedical, Inc. | 2025-08-15 |
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | 2025-07-16 |
| K250329 | GeniPhys Collymer Self-Assembling Scaffold | Geniphys, Inc. | 2025-06-25 |
| K242985 | CollOvine Wound Dressing | Ovigenex, LLC | 2025-06-20 |
| K243071 | Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc. | 2024-12-19 |