510(k) K253429
- Device
- Genadyne ASTRA NPWT
- Applicant
- Genadyne Biotechnologies, Inc.
- 510(k) number
- K253429
- Product code
- OMP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-12
- Date received
- 2025-10-01
- 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
- N
Related Records
Applicant Contact
- Contact
- Chien Ming Goh
- Address
- 16 Midland Ave. Hicksville NY US 11801 11801
FDA Registration Numbers
- 3010170586
- 1423537
- 2029275
- 3011987967
- 3005813597
- 3006808392
- 3002807523
- 2244478
- 3012084379
- 3002807314
- 3005178245
- 3007663067
- 3003622638
- 3007793449
- 1047843
- 9616088
- 3013857114
- 2011171
- 3031289255
- 1054241
- 9710603
- 3017397434
- 1928237
- 3011371066
- 3013652261
- 1064858
- 1721686
- 3032911850
- 3010149039
- 1921846
- 2435947
- 1055236
- 1419937
- 3004111573
- 1061927
- 3039256597
- 3010881832
- 3008754394
- 3011512432
- 3008806809
- 3003775292
- 1643817
- 3014209526
- 1061124
- 1526534
- 9613793
- 8030672
- 3010291427
- 3010223109
- 2027062
- 3010173425
- 3011582224
- 3021767551
- 2022435
- 9680001
- 1060680
- 3016904853
- 3010308146
- 1043214
- 2320762
- 3006538358
- 3007648359
- 3010588638
- 3010034780
- 3004022422
- 3003620648
- 3007048057
- 3007605720
- 3017036472
- 3015219237
- 3010155648
- 3008236846
- 3004727093
- 3008132398
- 3010610457
- 1643264
- 3005941719
- 3009176340
- 3009655869
- 1317547
Source Documents
Other 510(k) Records For Product Code OMP
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | 2026-05-21 |
| K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026-05-04 |
| 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 |
| K241515 | NEXA NPWT System | Nexa Medical Limited | 2024-07-26 |
| K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | 2024-05-24 |
| K241134 | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. | 2024-05-23 |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | 2024-04-18 |
| K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | 2024-04-17 |