Data / Medical devices / United States / Genadyne Biotechnologies, Inc.
Genadyne Biotechnologies, Inc.: FDA-registered device maker in Mystic, CT, United States, 9 510(k) clearances
Genadyne Biotechnologies, Inc. is registered with the FDA (registration 3039256597) in Mystic, CT, United States. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039256597
- Address
- 90 Welles Rd, Mystic, CT, United States, 06355
- Owner or operator
- Genvia Life Sciences, LLC (10093883)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- July 28, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| December 23, 2024 | K233614 | Genadyne DUO NPWT | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| June 12, 2023 | K221888 | Genadyne Hybrid Foam Dressings | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| June 1, 2022 | K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| September 27, 2019 | K182722 | XLR8 Abdominal Wound Dressing Kit | OMP | Substantially Equivalent | Genadyne Biotechnologies | accessdata.fda.gov |
| November 30, 2018 | K180840 | UNO Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| June 19, 2015 | K143726 | XLR8 PLUS (XLR8+) | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| April 30, 2015 | K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| March 26, 2015 | K141961 | GENADYNE SPIRO FOAM DRESSING KIT | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| June 29, 2010 | K092992 | A4-XLR8 FOAM DRESSING | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Mesh, Surgical, Polymeric
Updated December 23, 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.