V.A.C.ULTA Negative Pressure Wound Therapy System
FDA 510(k) clearance K162790 · decided 2017-01-26
Clearance details
- K-number
- K162790
- Device name
- V.A.C.ULTA Negative Pressure Wound Therapy System
- Applicant
- Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2016-10-04
- Decision date
- 2017-01-26
- Days to decision
- 114 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
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kci USA
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
| Record | Firm | Date |
|---|---|---|
| V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure recall (Z-0507-2025) | KCI USA, INC. | 2024-11-22 |