PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
by Smith & Nephew Medical Limited
510(k) K211318
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211318 | Date5 Jan 2022 | 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- Withdrawn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
- FDA applicant
- Smith Nephew Medical Limited
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The PICO 7 and PICO 14 are single-use negative pressure wound therapy systems designed for managing acute and chronic wounds, as well as closed surgical incisions. These devices apply controlled negative pressure to promote wound healing by enhancing granulation tissue formation, reducing edema, and improving perfusion. The PICO Fluid Management Packs complement the systems by facilitating exudate collection and management during therapy.
These systems are intended for use in clinical settings such as hospitals, surgical centers, and outpatient care facilities. Delivered sterile and intended for single-use only, they require no reprocessing. The PICO systems are classified as Class II medical devices under FDA regulations (21 CFR 878.4780) and have received FDA 510(k) clearance (K211318) as substantially equivalent to predicate devices. The PICO 7 and PICO 14 systems are available in specific configurations to accommodate varying wound sizes and clinical needs.
Other devices from Smith & Nephew Medical, Ltd.
Questions
AI-generated answers, 20 Sep 2026
Are the PICO 7 and PICO 14 systems reusable, or are they designed for single-use only?
The PICO 7 and PICO 14 systems are explicitly designed for single-use only and come sterile from the manufacturer. This eliminates the need for reprocessing, ensuring patient safety and hygiene in clinical settings like hospitals, surgical centers, and outpatient care.
What types of wounds or surgical sites are these devices intended to manage?
The PICO 7 and PICO 14 systems are intended for managing acute and chronic wounds, as well as closed surgical incisions. They apply controlled negative pressure to promote healing by reducing edema, improving perfusion, and enhancing granulation tissue formation.
How are the PICO 7 and PICO 14 systems classified under FDA regulations, and what does this mean for their use?
These devices are classified as Class II medical devices under FDA regulations (21 CFR 878.4780). This classification means they undergo a 510(k) clearance process to demonstrate substantial equivalence to a predicate device, ensuring they meet FDA safety and effectiveness standards before clinical use.
What role do the PICO Fluid Management Packs play in the therapy process?
The PICO Fluid Management Packs are designed to complement the PICO 7 and PICO 14 systems by facilitating the collection and management of exudate during negative pressure wound therapy. This helps maintain a clean wound environment and supports optimal healing conditions.
Are there different configurations available for the PICO 7 and PICO 14 systems to accommodate varying wound sizes?
Yes, the PICO 7 and PICO 14 systems are available in specific configurations tailored to accommodate different wound sizes and clinical needs. This flexibility allows clinicians to select the appropriate system based on the patient’s specific requirements.