Data / Medical devices / United States / Ets Wound Care LLC
Ets Wound Care LLC: FDA-registered device maker in Rolla, MO, United States, 1 510(k) clearance
Ets Wound Care LLC is registered with the FDA (registration 3013542522) in Rolla, MO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 15, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013542522
- Address
- 4030 Hypoint North, Rolla, MO, United States, 65401
- Owner or operator
- ETS Wound Care LLC (10054356)
- Roles
- Manufacturer
- First device listed
- March 10, 2017
- Registered through
- 2027
- Brand names listed
- MIRRAGEN Advanced Wound Matrix, MIRRASURG
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | 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 |
|---|---|---|---|---|---|---|
| September 15, 2016 | K161067 | Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirragen Advanced Wound Matrix, 1x6 | QSZ | Substantially Equivalent | Engineered Tissue Solutions, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 15, 2016. 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.