Data / Medical devices / United States / Cresilon Inc
Cresilon Inc: FDA-registered device maker in Brooklyn, NY, United States, 2 510(k) clearances
Cresilon Inc is registered with the FDA (registration 3012888343) in Brooklyn, NY, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 12, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012888343
- Address
- 86 34th St Ste D603/D604, Brooklyn, NY, United States, 11232
- Owner or operator
- Cresilon Inc (10091402)
- Roles
- Manufacturer
- First device listed
- September 20, 2024
- Registered through
- 2027
- Brand names listed
- TRAUMAGEL, TRAUMAGEL Hemostatic Gel, TRAUMAGEL;TRAUMAGEL Hemostatic Gel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 2025 | K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | QSY | Substantially Equivalent | Cresilon, Inc. | accessdata.fda.gov |
| August 14, 2024 | K240713 | TRAUMAGEL® | QSY | Substantially Equivalent | Cresilon, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.