PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
FDA 510(k) clearance K211318 · decided 2022-01-05
Clearance details
- K-number
- K211318
- Device name
- PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
- Applicant
- Smith Nephew Medical Limited
- Decision
- Substantially Equivalent
- Date received
- 2021-04-30
- Decision date
- 2022-01-05
- Days to decision
- 250 days
- Clearance type
- Traditional
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hull, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smith Nephew Medical Limited
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.