510(k) K223263
- Device
- Prevena Plus 125 Therapy Unit
- Applicant
- 3M
- 510(k) number
- K223263
- Product code
- QFC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-13
- Date received
- 2022-10-24
- Regulation
- 878.4783
- Classification name
- Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
- 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
- Teri Feeley
- Address
- 6203 Farinon Dr. San Antionio TX US 78247 78247
FDA Registration Numbers#
- 3014209526
- 3012358417
- 3006808392
- 3010173425
- 3005178245
- 3010223109
- 8043484
- 3008132398
- 3009897021
Source Documents#
Other 510(k) Records For Product Code QFC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203716 | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System | Smith and Nephew Medical Limited | 2021-12-14 |
| DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | Kci USA, Inc. | 2019-04-19 |