510(k) K210107
- Device
- Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
- Applicant
- Genadyne Biotechnologies, Inc.
- 510(k) number
- K210107
- Product code
- OMP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-01
- Date received
- 2021-01-15
- Regulation
- 878.4780
- Classification name
- Negative Pressure Wound Therapy Powered Suction Pump
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Saiken Ho
- Address
- 16 Midland Ave. Hicksville NY US 11801 11801
FDA Registration Numbers#
- 1721686
- 3006808392
- 1043549
- 3006581122
- 3004022422
- 3009746061
- 1319639
- 3030145672
- 1928237
- 3006538358
- 1921846
- 3007793449
- 3013857114
- 3010588638
- 2244478
- 1423537
- 3009655869
- 3002807523
- 3002807314
- 1222274
- 2435947
- 3008754394
- 2011171
- 3008132398
- 3016904853
- 1643817
- 3031289255
- 3011512432
- 3004681519
- 1061124
- 3007605720
- 3008320103
- 1043214
- 1061927
- 3009656988
- 3007648359
- 3004111573
- 2029275
- 3010155648
- 3010610457
- 3009176340
- 3005813597
- 3010881832
- 3017036472
- 3009538657
- 3003775292
- 2027062
- 1643264
- 3014683120
- 1317547
- 3009897021
- 3021767551
- 3034456223
- 3009518429
- 3011987967
- 3012084379
- 1526534
- 3010034780
- 1054241
- 3010308146
- 3008236846
- 3011582224
- 3013652261
- 1419937
- 3004727093
- 3007048057
- 2183744
- 8043484
- 3013557562
- 3017397434
- 3015219237
- 1047843
- 3039256597
- 9710603
- 1060680
- 3010223109
- 3008806809
- 3014209526
- 3008311916
- 3032911850
Source Documents#
Other 510(k) Records For Product Code OMP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | 2026-09-11 |
| K253263 | ConvaVAC™ Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | 2026-06-24 |
| K253199 | CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. | 2026-06-23 |
| K260646 | RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. | 2026-05-27 |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | 2026-05-21 |
| K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026-05-04 |
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | 2026-03-12 |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | 2025-11-21 |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | 2025-10-03 |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | 2025-09-11 |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | 2025-06-27 |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | Smith & Nephew Medical, Ltd. | 2025-02-18 |
| K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | 2024-12-23 |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | 2024-08-21 |
| K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | 2024-08-19 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases