Pico
510(k) K111170
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111170 | Date15 Dec 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OMP
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The PICO is a Negative Pressure Wound Therapy Powered Suction Pump, designed to apply controlled negative pressure to wounds or surgical incisions. It promotes wound healing by enhancing granulation tissue formation, reducing edema, and improving perfusion. The device is intended for use in clinical settings where negative pressure therapy is indicated for managing acute or chronic wounds, including post-surgical incisions and complex wounds resistant to conventional therapy.
The PICO system is supplied as a single-use device, featuring proprietary technology to deliver consistent negative pressure across the wound dressing. It is classified as a Class II medical device under FDA regulations (21 CFR 878.4780) and has received FDA 510K clearance for substantial equivalence. The device operates in clinical environments such as hospitals, surgical centers, and wound care clinics, with no MRI compatibility specified. Multiple model and reference codes are associated with its regulatory submissions, ensuring compliance with U.S. medical device standards.
Other devices from Smith & Nephew, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PICO Negative Pressure Wound Therapy Pump used for?
The PICO is designed to apply controlled negative pressure to wounds or surgical incisions, helping to enhance granulation tissue formation, reduce edema, and improve perfusion. This promotes faster healing in clinical settings for acute or chronic wounds, including post-surgical incisions and complex wounds that do not respond well to conventional treatments.
Is the PICO device single-use or reusable?
The PICO is supplied as a single-use device. This design ensures patient safety and hygiene by eliminating the need for reprocessing, which can introduce contamination risks. Single-use also aligns with clinical best practices for wound care to maintain sterility and consistency in therapy.
What clinical environments is the PICO intended for?
The PICO is intended for use in clinical settings such as hospitals, surgical centers, and wound care clinics. It is not specified as MRI-compatible, so its use must be carefully considered in environments where MRI procedures are performed nearby to avoid interference.
How does the PICO ensure consistent negative pressure delivery?
The PICO incorporates proprietary technology to deliver consistent negative pressure across wound dressings. This ensures reliable therapeutic outcomes by maintaining a stable pressure environment, which is critical for promoting wound healing and reducing complications like infection or delayed healing.
What regulatory approvals does the PICO hold?
The PICO has received FDA 510K clearance, demonstrating substantial equivalence to a predicate device under the FDA’s regulatory framework. It is classified as a Class II medical device under 21 CFR 878.4780, reflecting its role in managing wound therapy with moderate risk. The device complies with U.S. medical device standards through multiple regulatory submissions.