Genadyne UNO Plus Negative Pressure Wound Therapy System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210107 FDA 510(k)
- FDA Product Code
- OMP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Genadyne UNO Plus Negative Pressure Wound Therapy System is a powered suction pump designed for negative pressure wound therapy (NPWT). It promotes wound healing by applying controlled negative pressure to the wound bed, facilitating the removal of excess exudate, infectious material, and tissue debris to create a moist healing environment.
This system is intended for single-use applications and is supplied as a portable, lightweight device measuring 111.13 mm × 76.2 mm × 41.28 mm (4 3/8″ × 3″ × 1 5/8″) and weighing 220 grams. It includes an integrated PC interface for downloading therapy alerts and features. The device is classified as Class II under FDA regulations (K210107) and has received FDA 510(k) clearance and MDD authorization. No MRI safety information is specified.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: UNO - Genadyne, UNO Plus - Genadyne, GENADYNE UNO+ USER MANUAL Pdf Download | ManualsLib, GENADYNE UNO Plus Negative Pressure Wound Therapy System User Guide
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210107 | Class II | Active |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
Sources (2)
- FDA 510(k) K210107 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026