UNO Negative Pressure Wound Therapy System
FDA 510(k) K161599 · Genadyne Biotechnologies, Inc.
510(k) numberK161599
Submission
- Device name
- UNO Negative Pressure Wound Therapy System
- Applicant
- Genadyne Biotechnologies, Inc.
Hicksville, NY, US - Received
- June 9, 2016
- Decision date
- April 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Other 510(k)s with product code OMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K253263 | ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited, Gdc Building | 06/24/2026SE |
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | CG Bio Co., Ltd. | 06/23/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical, Ltd. | 05/27/2026SE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500)OMP · Special | Cork Medical | 05/21/2026SE |
| K254019 | Wound Geni NPWT SystemOMP · Traditional | Bechtel Medical, Inc. | 05/04/2026SE |
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/12/2026SE |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | Deroyal Industries, Inc. | 11/21/2025SE |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical Devices | 10/03/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
More from Smith & Nephew Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | 03/12/2026SE |
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…BZD · Special | 12/31/2024SE |
| K233614 | Genadyne DUO NPWTOMP · Traditional | 12/23/2024SE |
| K221888 | Genadyne Hybrid Foam DressingsOMP · Traditional | 06/12/2023SE |
| K221891 | UNO Negative Pressure Wound Therapy SystemOMP · Special | 12/14/2022SE |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemOMP · Traditional | 06/01/2022SE |
| K190028 | Uno 30OMP · Traditional | 01/15/2020SE |
| K182722 | XLR8 Abdominal Wound Dressing KitOMP · Traditional | 09/27/2019SE |
| K180840 | UNO Negative Pressure Wound Therapy SystemOMP · Traditional | 11/30/2018SE |
| K143726 | XLR8 Plus (XLR8+)OMP · Traditional | 06/19/2015SE |
Questions and answers
When was UNO Negative Pressure Wound Therapy System cleared by the FDA?
UNO Negative Pressure Wound Therapy System (K161599) received a 510(k) decision of Substantially Equivalent on April 6, 2017, 301 days after the submission was received.
What is the product code of K161599?
The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.