510(k) K253521
- Device
- ECMT-100 WMD
- Applicant
- Ecm Therapeutics, Inc.
- 510(k) number
- K253521
- Product code
- KGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-18
- Date received
- 2025-11-13
- 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
- Russell Kronengold
- Address
- 118 Marshall Dr. Warrendale PA US 15086 15086
FDA Registration Numbers#
- 3010894343
- 3009973323
- 3012973796
- 1648579
- 2530154
- 3004170064
- 3009317711
- 3011649314
- 3004799623
- 3007663067
- 3019356409
- 3010600625
- 3003300673
- 3043861816
- 1058584
- 3014982332
- 3010668881
- 3017297225
- 3030067857
- 3031600472
- 3008102042
- 2431866
- 1066741
- 3042708438
- 1043214
- 3031238659
- 3042750477
- 3015238043
- 3011276344
- 1319660
- 3014498807
- 3015980493
- 3008374791
- 3018348
- 3003768919
- 3016904853
- 3015542130
- 3015282703
- 3012102437
- 2135152
- 3013517171
- 2024024
- 3013012623
- 3006802076
- 3009882464
- 8043396
- 3015058854
- 3009504230
- 3017391151
- 3031743608
- 2435946
- 1650372
- 3004431266
- 3015946784
- 1929833
- 3007735241
- 3004189237
- 2245539
- 3025316685
- 2032542
- 3003636207
- 3010155661
- 1645368
- 1835959
- 1720929
- 3016429246
- 3017633586
- 3012535730
- 3010097129
- 1450662
- 3034456223
- 3027419979
- 1064858
- 3008770963
- 3010187826
- 1649518
- 3004146122
- 1000393132
- 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 |
| K253204 | Catalyze | BioTissue Holdings, Inc. | 2026-06-05 |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | 2026-06-03 |
| K253974 | Roosin Collagen Dressing | 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 |
| 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 |