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
FDA 510(k) clearance K203716 · decided 2021-12-14
Clearance details
- K-number
- K203716
- Device name
- 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
- Applicant
- Smith and Nephew Medical Limited
- Decision
- Substantially Equivalent
- Date received
- 2020-12-21
- Decision date
- 2021-12-14
- Days to decision
- 358 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
- Hull, GB
- 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 |
| PREVENA 125 and PREVENA PLUS 125 Therapy Units (DEN180013) | Kci USA, Inc. | 2019-04-19 |
Recalls involving this device
No recalls on record reference this clearance.