Prevena Plus 125 Therapy Unit
FDA 510(k) clearance K223263 · decided 2023-02-13
Clearance details
- K-number
- K223263
- Device name
- Prevena Plus 125 Therapy Unit
- Applicant
- 3M
- Decision
- Substantially Equivalent
- Date received
- 2022-10-24
- Decision date
- 2023-02-13
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- QFC
- Device class
- 2
- Regulation number
- 878.4783
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Antionio, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 (K203716) | Smith and Nephew Medical Limited | 2021-12-14 |
| PREVENA 125 and PREVENA PLUS 125 Therapy Units (DEN180013) | Kci USA, Inc. | 2019-04-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and recall (Z-1175-2025) | KCI USA, INC. | 2025-02-14 |