PREVENA 125 and PREVENA PLUS 125 Therapy Units
FDA 510(k) clearance DEN180013 · decided 2019-04-19
Clearance details
- K-number
- DEN180013
- Device name
- PREVENA 125 and PREVENA PLUS 125 Therapy Units
- Applicant
- Kci USA, Inc.
- Decision
- Unknown
- Date received
- 2018-03-15
- Decision date
- 2019-04-19
- Days to decision
- 400 days
- Clearance type
- Direct
- Product code
- QFC
- Device class
- 2
- Regulation number
- 878.4783
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Antonio, 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 |
|---|---|---|
| Prevena Plus 125 Therapy Unit (K223263) | 3M | 2023-02-13 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.