Data / Medical devices / United States / Bionova Medical, Inc.
Bionova Medical, Inc.: FDA-registered device maker in Germantown, TN, United States, 4 510(k) clearances
Bionova Medical, Inc. is registered with the FDA (registration 3009973323) in Germantown, TN, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 31, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009973323
- Address
- 3012 Centre Oak Way Ste 102, Germantown, TN, United States, 38138
- Owner or operator
- Bionova Medical, Inc. (10042462)
- Roles
- Specification developer
- First device listed
- January 2, 2014
- Registered through
- 2026
- Brand names listed
- Foundation DRS Solo, Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo, Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo, Sentrex BioSponge MPD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Specification developer | 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 31, 2024 | K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | FRO | Substantially Equivalent | Bionova Medical, Inc. | accessdata.fda.gov |
| August 21, 2024 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | FRO | Substantially Equivalent | Bionova Medical, Inc. | accessdata.fda.gov |
| November 13, 2023 | K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | KGN | Substantially Equivalent | Bionova Medical, Inc. | accessdata.fda.gov |
| April 5, 2013 | K123961 | SENTREX BIOSPONGE MPD | KGN | Substantially Equivalent | Bionova Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 31, 2024. 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.