Cleared Traditional

K203716 - 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 (FDA 510(k) Clearance)

K203716 · Smith and Nephew Medical Limited · General & Plastic Surgery device
Dec 2021
Decision
358d
Days
Class 2
Risk

K203716 is an FDA 510(k) clearance for the 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. This device is classified as a Negative Pressure Wound Therapy Device For Reduction Of Wound Complications (Class II - Special Controls, product code QFC).

Submitted by Smith and Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on December 14, 2021, 358 days after receiving the submission on December 21, 2020.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4783. A Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Is A Powered Suction Pump Intended For Wound Management And Reduction Of Wound Complications Via Application Of Negative Pressure To The Wound, Which Removes Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. This Device Type Is Intended For Use With Wound Dressings Classified Under 21 Cfr 878.4780. This Classification Does Not Include Devices Intended For Organ Space Wounds..

Submission Details

510(k) Number K203716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2020
Decision Date December 14, 2021
Days to Decision 358 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code QFC - Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Device Class Class II - Special Controls
CFR Regulation 21 CFR 878.4783
Definition A Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Is A Powered Suction Pump Intended For Wound Management And Reduction Of Wound Complications Via Application Of Negative Pressure To The Wound, Which Removes Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. This Device Type Is Intended For Use With Wound Dressings Classified Under 21 Cfr 878.4780. This Classification Does Not Include Devices Intended For Organ Space Wounds.