510(k) K260532
- Device
- Derma-Gide
- Applicant
- Geistlich Pharma AG
- 510(k) number
- K260532
- Product code
- KGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-19
- Date received
- 2026-02-17
- Classification name
- Wound Dressing With Animal-Derived Material(S)
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Erik Wirth
- Address
- Bahnhofstrasse 40 Wolhusen CH 6110 6110
FDA Registration Numbers
- 3008374791
- 3013517171
- 1450662
- 3012823434
- 3010097129
- 3008770963
- 3013820501
- 1645368
- 3011276344
- 1720734
- 3039169663
- 1650372
- 2245539
- 3004189237
- 3016615875
- 3013012623
- 3015442987
- 1066741
- 8043484
- 3014820861
- 3027419979
- 1225991
- 3011649314
- 3042708438
- 1319660
- 9614442
- 2135152
- 3032911850
- 3015980493
- 1064858
- 2024024
- 2245437
- 3012535730
- 2249852
- 3017297225
- 3009317711
- 1043214
- 3010600625
- 3025316685
- 2530154
- 3003300673
- 3002907620
- 3015525200
- 3007594734
- 1649518
- 3010155661
- 9680579
- 1058584
- 3007738736
- 1835959
- 3031238659
- 3010894343
- 3015309358
- 3015238043
- 3015282703
- 3017399129
- 2032542
- 3011191255
- 3010668881
- 3007663067
- 3016429246
- 3003636207
- 1417592
- 3006802076
- 1000393132
- 3017660750
- 3005433617
- 3005920706
- 3007735241
- 3004146122
- 2245304
- 3031743608
- 3018348
- 3003768919
- 3014146451
- 2431866
- 3008102042
- 1929833
- 1720929
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 |
| 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 |
| K241904 | DermiSphere Dermal Template | Fesariustherapeutics, Inc. | 2025-01-06 |
| K243071 | Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc. | 2024-12-19 |