Data / Medical devices / United States / Viscus Biologics, LLC.
Viscus Biologics, LLC.: FDA-registered device maker in Cleveland, OH, United States, 3 510(k) clearances
Viscus Biologics, LLC. is registered with the FDA (registration 3013012623) in Cleveland, OH, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 27, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013012623
- Address
- 26309 Miles Road Suite 1, Cleveland, OH, United States, 44128
- Owner or operator
- Viscus Biologics LLC (10052742)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 26, 2016
- Registered through
- 2026
- Brand names listed
- BaseMEM, FibermarX, FibermarX Radiopaque Tissue Marker, Puracol Ultra Powder, Radiopaque Tissue Marker, VeraForm Adaptable Tissue Marker
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | 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 |
|---|---|---|---|---|---|---|
| February 27, 2019 | K190155 | FibermarX Radiopaque Tissue Marker | IYE | Substantially Equivalent | Viscus Biologics, LLC | accessdata.fda.gov |
| June 2, 2017 | K170026 | Radiopaque Tissue Marker | NEU | Substantially Equivalent | Viscus Biologics, LLC | accessdata.fda.gov |
| June 26, 2015 | K140820 | XENOMEM WOUND MATRIX | KGN | Substantially Equivalent | Viscus Biologics, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Marker, Radiographic, Implantable
- All makers of Dressing, Wound, Drug
- All makers of Accelerator, Linear, Medical
Updated February 27, 2019. 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.