Data / Medical devices / United States / Stellen Medical, LLC
Stellen Medical, LLC: FDA-registered device maker in Saint Paul, MN, United States, 2 510(k) clearances
Stellen Medical, LLC is registered with the FDA (registration 2132242) in Saint Paul, MN, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 14, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2132242
- FEI number
- 1000143837
- Address
- 1290 Hammond RD., Saint Paul, MN, United States, 55110
- Owner or operator
- STELLEN MEDICAL, LLC (9008931)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 13, 1994
- Registered through
- 2026
- Brand names listed
- Brennen Skin Graft Mesher, GlucanPro Cream, Proformix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Manufacturer | accessdata.fda.gov |
| Expander, Surgical, Skin Graft | FZW | 1 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 14, 2011 | K111436 | PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX | FTM | Substantially Equivalent | Brennen Medical, LLC | accessdata.fda.gov |
| October 2, 2000 | K002077 | GLUCANPRO CREAM | MGQ | Substantially Equivalent | Brennen Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- All makers of Expander, Surgical, Skin Graft
- All makers of Mesh, Surgical
Updated October 14, 2011. 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.