510(k) K203716

Device

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

510(k) number

K203716

Product code

QFC

Decision

Substantially Equivalent (SESE)

Decision date

2021-12-14

Date received

2020-12-21

Regulation

878.4783

Classification name

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

Medical specialty

General, Plastic Surgery

Review panel

General, Plastic Surgery

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No